Rybrevant (amivantamab-vmjw) Injection

Company: Janssen Pharmaceuticals, Inc.
Date of Approval: May 21, 2021
Treatment for: Non-Small Cell Lung Cancer
Rybrevant (amivantamab-vmjw) is a bispecific EGF receptor-directed and MET receptor-directed antibody indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test.

Empaveli (pegcetacoplan) Injection

Company: Apellis Pharmaceuticals, Inc.
Date of Approval: May 14, 2021
Treatment for: Paroxysmal Nocturnal Hemoglobinuria
Empaveli (pegcetacoplan) is a targeted C3 inhibitor for the treatment of paroxysmal nocturnal hemoglobinuria (PNH).

Zynrelef (bupivacaine and meloxicam) Injection - formerly HTX-011

Company: Heron Therapeutics, Inc.
Date of Approval: May 12, 2021
Treatment for: Postoperative Pain
Zynrelef (bupivacaine and meloxicam) is an extended-release, fixed-dose combination of the local anesthetic bupivacaine and the nonsteroidal anti-inflammatory drug (NSAID) meloxicam indicated for the management of postoperative pain.

Kloxxado (naloxone hydrochloride) Nasal Spray

Company: Hikma Pharmaceuticals PLC
Date of Approval: April 30, 2021
Treatment for: Opioid Overdose
Kloxxado (naloxone hydrochloride) nasal spray is an opioid antagonist indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression, for adult and pediatric patients.

Zynlonta (loncastuximab tesirine-lpyl) Injection

Company: ADC Therapeutics SA
Date of Approval: April 23, 2021
Treatment for: Diffuse Large B-cell Lymphoma
Zynlonta (loncastuximab tesirine-lpyl) is a CD19-directed antibody and alkylating agent conjugate indicated for the treatment of adult patients with relapsed or refractory large B-cell lymphoma.

Jemperli (dostarlimab-gxly) Injection

Company: GlaxoSmithKline
Date of Approval: April 22, 2021
Treatment for: Endometrial Carcinoma
Jemperli (dostarlimab-gxly) is a programmed death receptor-1 (PD-1)–blocking antibody for the treatment of women with mismatch repair deficient (dMMR) recurrent or advanced endometrial cancer.

Nextstellis (drospirenone and estetrol) Tablets

Company: Mayne Pharma US
Date of Approval: April 15, 2021
Treatment for: Contraception
Nextstellis (drospirenone and estetrol) is a progestin and estrogen combination indicated for use by females of reproductive potential to prevent pregnancy.

Qelbree (viloxazine hydrochloride) Extended Release Capsules

Company: Supernus Pharmaceuticals, Inc.
Date of Approval: April 2, 2021
Treatment for: Attention Deficit Hyperactivity Disorder (ADHD)
Qelbree (viloxazine hydrochloride) is a serotonin norepinephrine modulating agent (SNMA) for the treatment of attention deficit hyperactivity disorder (ADHD) in pediatric patients 6 to 17 years of age.

Abecma (idecabtagene vicleucel) Suspension for Intravenous Infusion

Company: Bristol-Myers Squibb Company
Date of Approval: March 26, 2021
Treatment for: Multiple Myeloma
Abecma (idecabtagene vicleucel) is a B-cell maturation antigen (BCMA)-directed genetically modified autologous chimeric antigen receptor (CAR) T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.

Roszet (ezetimibe and rosuvastatin) Tablets

Company: Althera Life Sciences, LLC
Date of Approval: March 23, 2021
Treatment for: Hyperlipidemia, Homozygous Familial Hypercholesterolemia
Roszet (ezetimibe and rosuvastatin) is an intestinal cholesterol inhibitor and HMG Co-A reductase inhibitor (statin) combination indicated to reduce low-density lipoprotein cholesterol (LDL-C) in primary non-familial hyperlipidemia and homozygous familial hypercholesterolemia (HoFH).

Zegalogue (dasiglucagon) Injection

Company: Zealand Pharma A/S
Date of Approval: March 22, 2021
Treatment for: Hypoglycemia
Zegalogue (dasiglucagon) is a glucagon analog antihypoglycemic agent for the treatment of severe hypoglycemia in diabetes patients aged 6 years and older.

Ponvory (ponesimod) Tablets

Company: Janssen Pharmaceuticals, Inc.
Date of Approval: March 18, 2021
Treatment for: Multiple Sclerosis
Ponvory (ponesimod) is a selective sphingosine-1-phosphate receptor 1 (S1P1) modulator indicated for the treatment of adults with relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

Kimyrsa (oritavancin) for Injection

Company: Melinta Therapeutics
Date of Approval: March 12, 2021
Treatment for: Skin and Structure Infection
Kimyrsa (oritavancin) is a lipoglycopeptide antibiotic for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSI) caused by designated Gram-positive microorganisms, including methicillin-resistant Staphylococcus aureus (MRSA).

Fotivda (tivozanib) Capsules

Company: AVEO Oncology
Date of Approval: March 10, 2021
Treatment for: Renal Cell Carcinoma
Fotivda (tivozanib) is a vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI) indicated for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies.

Azstarys (dexmethylphenidate and serdexmethylphenidate) Capsules

Company: KemPharm, Inc.
Date of Approval: March 2, 2021
Treatment for: Attention Deficit Hyperactivity Disorder (ADHD)
Azstarys (dexmethylphenidate and serdexmethylphenidate) is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years of age and older.

Nulibry (fosdenopterin) Injection

Company: BridgeBio Pharma, Inc.
Date of Approval: February 26, 2021
Treatment for: Molybdenum Cofactor Deficiency (MoCD) Type A
Nulibry (fosdenopterin) is a cyclic pyranopterin monophosphate (cPMP) substrate replacement therapy for the treatment of patients with molybdenum cofactor deficiency (MoCD) Type A.

Pepaxto (melphalan flufenamide) Injection

Company: Oncopeptides AB
Date of Approval: February 26, 2021
Treatment for: Multiple Myeloma
Pepaxto (melphalan flufenamide) is an anticancer peptide-drug conjugate indicated for use in combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma.

Amondys 45 (casimersen) Injection

Company: Sarepta Therapeutics
Date of Approval: February 25, 2021
Treatment for: Duchenne Muscular Dystrophy
Amondys 45 (casimersen) is an antisense oligonucleotide for the treatment of patients with Duchenne muscular dystrophy (DMD) who have genetic mutations that are amenable to skipping exon 45 of the Duchenne gene.

Cosela (trilaciclib) for Injection

Company: G1 Therapeutics, Inc.
Date of Approval: February 12, 2021
Treatment for: Small Cell Lung Cancer Myelopreservation Therapy
Cosela (trilaciclib) is a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor myelopreservation therapy for use in patients with small cell lung cancer (SCLC) who are receiving chemotherapy.

Evkeeza (evinacumab-dgnb) Injection

Company: Regeneron Pharmaceuticals, Inc.
Date of Approval: February 11, 2021
Treatment for: Homozygous Familial Hypercholesterolemia
Evkeeza (evinacumab-dgnb) is an angiopoietin-like 3 (ANGPTL3) inhibitor indicated as an adjunct to other low-density lipoprotein-cholesterol (LDL-C) lowering therapies for the treatment of adult and pediatric patients, aged 12 years and older, with homozygous familial hypercholesterolemia (HoFH).

Posimir (bupivacaine) Solution for Infiltration Use

Date of Approval: February 1, 2021
Company: Durect Corporation
Treatment for: Post-Surgical Pain
Posimir (bupivacaine) is a sustained-release anamide local anesthetic formulation indicated for post-surgical pain reduction following arthroscopic subacromial decompression shoulder surgery.

Tepmetko (tepotinib) Tablets

Date of Approval: February 3, 2021
Company: EMD Serono, Inc.
Treatment for: Non-Small Cell Lung Cancer
Tepmetko (tepotinib) is an oral MET inhibitor for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations.

Ukoniq (umbralisib) Tablets

Date of Approval: February 5, 2021
Company: TG Therapeutics, Inc.
Treatment for: Marginal Zone Lymphoma; Follicular Lymphoma
Ukoniq (umbralisib) is a dual inhibitor of phosphoinositide 3 kinase (PI3K) delta and casein kinase 1 (CK1) epsilon for the treatment of marginal zone lymphoma (MZL) and follicular Lymphoma (FL).

Breyanzi (lisocabtagene maraleucel) Suspension for Intravenous Infusion

Date of Approval: February 5, 2021
Company: Bristol-Myers Squibb Company
Treatment for: Large B-Cell Lymphoma
Breyanzi (lisocabtagene maraleucel) is a chimeric antigen receptor (CAR) T-cell therapy for the treatment of adult patients with relapsed or refractory large B-cell lymphoma (LBCL).

Evkeeza (evinacumab-dgnb) Injection

Date of Approval: February 11, 2021
Company: Regeneron Pharmaceuticals, Inc.
Treatment for: Homozygous Familial Hypercholesterolemia
Evkeeza (evinacumab-dgnb) is an angiopoietin-like 3 (ANGPTL3) inhibitor indicated as an adjunct to other low-density lipoprotein-cholesterol (LDL-C) lowering therapies for the treatment of adult and pediatric patients, aged 12 years and older, with homozygous familial hypercholesterolemia (HoFH).

Cosela (trilaciclib) for Injection

Date of Approval: February 12, 2021
Company: G1 Therapeutics, Inc.
Treatment for: Small Cell Lung Cancer Myelopreservation Therapy
Cosela (trilaciclib) is a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor myelopreservation therapy for use in patients with small cell lung cancer (SCLC) who are receiving chemotherapy.

Amondys 45 (casimersen) Injection

Date of Approval: February 25, 2021
Company: Sarepta Therapeutics, Inc.
Treatment for: Duchenne Muscular Dystrophy
Amondys 45 (casimersen) is an antisense oligonucleotide for the treatment of patients with Duchenne muscular dystrophy (DMD) who have genetic mutations that are amenable to skipping exon 45 of the Duchenne gene.

Amondys 45 (casimersen) FDA Approval History

Pepaxto (melphalan flufenamide) Injection
Date of Approval: February 26, 2021
Company: Oncopeptides AB
Treatment for: Multiple Myeloma
Pepaxto (melphalan flufenamide) is an anticancer peptide-drug conjugate indicated for use in combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma.

Nulibry (fosdenopterin) Injection

Date of Approval: February 26, 2021
Company: BridgeBio Pharma, Inc.
Treatment for: Molybdenum Cofactor Deficiency (MoCD) Type A
Nulibry (fosdenopterin) is a cyclic pyranopterin monophosphate (cPMP) substrate replacement therapy for the treatment of patients with molybdenum cofactor deficiency (MoCD) Type A.

Verquvo (vericiguat) Tablets

Date of Approval: January 19, 2021
Company: Merck
Treatment for: Heart Failure with Reduced Ejection Fraction (HFrEF)
Verquvo (vericiguat) is a soluble guanylate cyclase (sGC) stimulator indicated to reduce the risk of cardiovascular death and heart failure (HF) hospitalization following a hospitalization for heart failure or need for outpatient IV diuretics, in adults with symptomatic chronic HF and ejection fraction less than 45%.

Cabenuva (cabotegravir and rilpivirine) Extended-Release Injectable Suspension ( Co-Packaged)

Date of Approval: January 21, 2021
Company: ViiV Healthcare
Treatment for: HIV Infection
Cabenuva (cabotegravir and rilpivirine) is a long-acting, injectable regimen of the HIV-1 integrase strand transfer inhibitor (INSTI) cabotegravir, and the HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI) rilpivirine indicated as a complete regimen for the treatment of HIV-1 infection in adults.

Lupkynis (voclosporin) Capsules

Date of Approval: January 22, 2021
Company: Aurinia Pharmaceuticals Inc.
Treatment for: Lupus Nephritis
Lupkynis (voclosporin) is a calcineurin-inhibitor immunosuppressant indicated in combination with a background immunosuppressive therapy regimen for the treatment of adult patients with active lupus nephritis (LN).

Ayvakit (avapritinib) Tablets

Date of Approval: January 9, 2020
Company: Blueprint Medicines Corporation
Treatment for: Gastrointestinal Stromal Tumor
Ayvakit (avapritinib) is a kinase inhibitor for the treatment of PDGFRα exon 18 mutant gastrointestinal stromal tumors (GIST). FDA Approves Ayvakit (avapritinib) for the Treatment of Adults with Unresectable or Metastatic PDGFRA Exon 18 Mutant Gastrointestinal Stromal Tumor

Valtoco (diazepam) Nasal Spray

Date of Approval: January 10, 2020
Company: Neurelis, Inc.
Treatment for: Epilepsy
Valtoco (diazepam) is a benzodiazepine nasal spray for the short-term treatment of epilepsy cluster seizures. FDA Approves Valtoco (diazepam nasal spray) as a Seizure Rescue Treatment

Numbrino (cocaine hydrochloride) Nasal Solution

Date of Approval: January 10, 2020
Company: Lannett Company, Inc.
Treatment for: Nasal Anesthesia
Numbrino (cocaine hydrochloride) nasal solution is a local anesthetic indicated for the introduction of local anesthesia of the mucous membranes for diagnostic procedures and surgeries on or through the nasal cavities of adults. FDA Approves Numbrino (cocaine hydrochloride) Nasal Solution for Nasal Anesthesia

Tepezza (teprotumumab-trbw) Injection

Date of Approval: January 21, 2020
Company: Horizon Therapeutics plc
Treatment for: Thyroid Eye Disease
Tepezza (teprotumumab-trbw) is a fully human monoclonal antibody (mAb) and a targeted inhibitor of the insulin-like growth factor 1 receptor (IGF-1R) for the treatment of active thyroid eye disease (TED). FDA Approves Tepezza (teprotumumab-trbw) for the Treatment of Thyroid Eye Disease (TED)

Tazverik (tazemetostat) Tablets

Date of Approval: January 23, 2020
Company: Epizyme, Inc.
Treatment for: Epithelioid Sarcoma
Tazverik (tazemetostat) is a methyltransferase inhibitor for the treatment of patients with epithelioid sarcoma. FDA Approves Tazverik (tazemetostat) for the Treatment of Patients with Epithelioid Sarcoma

Trijardy XR (empagliflozin, linagliptin and metformin hydrochloride) Extended-Release Tablets

Date of Approval: January 27, 2020
Company: Boehringer Ingelheim and Eli Lilly and Company
Treatment for: Diabetes Type 2
Trijardy XR (empagliflozin/linagliptin/metformin hydrochloride) is a fixed-dose combination of the sodium-glucose cotransporter 2 (SGLT2) inhibitor empagliflozin (Jardiance), the dipeptidyl peptidase-4 (DPP-4) inhibitor linagliptin (Tradjenta) and the biguanide metformin hydrochloride indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. FDA Approves Trijardy XR (empagliflozin/linagliptin/metformin) for Type 2 Diabetes in Adults

Monoferric (ferric derisomaltose) Injection

Date of Approval: January 16, 2020
Company: Pharmacosmos Therapeutics Inc.
Treatment for: Iron Deficiency Anemia
Monoferric (ferric derisomaltose) is an intravenous iron replacement product indicated for the treatment of iron deficiency anemia. FDA Approves Monoferric (ferric derisomaltose) Injection for the Treatment of Iron Deficiency Anemia

Palforzia (Peanut (Arachis hypogaea) Allergen Powder-dnfp) - formerly AR101

Date of Approval: January 31, 2020
Company: Aimmune Therapeutics, Inc.
Treatment for: Peanut Allergy
Palforzia (Peanut (Arachis hypogaea) Allergen Powder-dnfp) is an oral immunotherapy indicated to help reduce the severity of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut. FDA Approves Palforzia [Peanut (Arachis hypogaea) Allergen Powder-dnfp] as First Treatment for Peanut Allergy

Audenz (influenza A (H5N1) monovalent vaccine, adjuvanted) Injection

Date of Approval: January 31, 2020
Company: Seqirus
Treatment for: Influenza Prophylaxis
Audenz (influenza A (H5N1) monovalent vaccine, adjuvanted) is a cell-based influenza vaccine designed to protect against influenza A (H5N1) in the event of a pandemic. FDA Approves Audenz (Influenza A (H5N1) Monovalent Vaccine, Adjuvanted) as First-Ever Adjuvanted, Cell-Based Pandemic Influenza A (H5N1) Vaccine

Pemfexy (pemetrexed) Injection

Date of Approval: February 8, 2020
Company: Eagle Pharmaceuticals, Inc.
Treatment for: Non-Small Cell Lung Cancer, Malignant Pleural Mesothelioma
Pemfexy (pemetrexed for injection) is a branded alternative to Alimta for the treatment of nonsquamous non-small cell lung cancer and malignant pleural mesothelioma. FDA Approves Pemfexy (pemetrexed for injection) as a Branded Alternative to Alimta

Pizensy (lactitol) Powder for Oral Solution

Date of Approval: February 12, 2020
Company: Braintree Laboratories, Inc.
Treatment for: Chronic Idiopathic Constipation
Pizensy (lactitol) is an osmotic laxative indicated for the treatment of chronic idiopathic constipation (CIC) in adults. FDA Approves Pizensy (lactitol) for the Treatment of Chronic Idiopathic Constipation (CIC)

Twirla (ethinyl estradiol and levonorgestrel) Transdermal System

Date of Approval: February 14, 2020
Company: Agile Therapeutics, Inc.
Treatment for: Contraception
Twirla (ethinyl estradiol and levonorgestrel transdermal system) is a low-dose combined hormonal contraceptive patch for birth control. FDA Approves Twirla (levonorgestrel and ethinyl estradiol) Contraceptive Patch

Anjeso (meloxicam) Injection

Date of Approval: February 20, 2020
Company: Baudax Bio, Inc.
Treatment for: Pain
Anjeso (meloxicam) is a non-steroidal anti-inflammatory drug (NSAID) injection indicated for use in adults for the management of moderate-to-severe pain, alone or in combination with non-NSAID analgesics. FDA Approves Anjeso (meloxicam injection) for the Management of Moderate to Severe Pain

Nexletol (bempedoic acid) Tablets

Date of Approval: February 21, 2020
Company: Esperion Therapeutics, Inc.
Treatment for: Heterozygous Familial Hypercholesterolemia
Nexletol (bempedoic acid) is a first-in-class, adenosine triphosphate-citrate lyase (ACL) inhibitor for the treatment of adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional lowering of LDL-Cholesterol. FDA Approves Nexletol (bempedoic acid) to Lower LDL-Cholesterol

Vyepti (eptinezumab-jjmr) Injection

Date of Approval: February 21, 2020
Company: Lundbeck
Treatment for: Migraine Prophylaxis
Vyepti (eptinezumab-jjmr) is a calcitonin gene-related peptide antagonist indicated for the prevention of migraine in adults. FDA Approves Vyepti (eptinezumab-jjmr) Intravenous Injection for the Preventive Treatment of Migraine

Nexlizet (bempedoic acid and ezetimibe) Tablets

Date of Approval: February 26, 2020
Company: Esperion Therapeutics
Treatment for: Heterozygous Familial Hypercholesterolemia
Nexlizet (bempedoic acid and ezetimibe) is an adenosine triphosphate-citrate lyase (ACL) inhibitor and a cholesterol absorption inhibitor combination indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional lowering of LDL-C. FDA Approves Nexlizet (bempedoic acid and ezetimibe) to Lower LDL-Cholesterol

Barhemsys (amisulpride) Injection

Date of Approval: February 26, 2020
Company: Acacia Pharma
Treatment for: Nausea/Vomiting -- Postoperative
Barhemsys (amisulpride) is a dopamine-2 (D2) antagonist for the management of post-operative nausea and vomiting (PONV). FDA Approves Barhemsys (amisulpride) for the Treatment and Prevention of Postoperative Nausea and Vomiting

Nurtec ODT (rimegepant) Orally Disintegrating Tablets (ODT)


Date of Approval: February 27, 2020
Company: Biohaven Pharmaceutical Holding Company Ltd.
Treatment for: Migraine
Nurtec ODT (rimegepant) is an orally-dosed calcitonin gene-related peptide (CGRP) receptor antagonist for the acute treatment of migraine. FDA Approves Nurtec ODT (rimegepant) for the Acute Treatment of Migraine in Adults

Advil Dual Action (ibuprofen and acetaminophen) Tablets

Date of Approval: February 28, 2020
Company: GSK Consumer Healthcare
Treatment for: Pain
Advil Dual Action (ibuprofen with acetaminophen) is an over-the-counter (OTC) fixed-dose combination of ibuprofen (the nonsteroidal anti-inflammatory drug (NSAID) contained in Advil) and acetaminophen (the active ingredient in Tylenol) for the relief of pain. FDA Approves Advil Dual Action (ibuprofen and acetaminophen) as an Over-the-Counter Pain Treatment

Pizensy (lactitol) Powder for Oral Solution

Date of Approval: February 12, 2020
Company: Braintree Laboratories, Inc.
Treatment for: Chronic Idiopathic Constipation
Pizensy (lactitol) is an osmotic laxative indicated for the treatment of chronic idiopathic constipation (CIC) in adults. FDA Approves Pizensy (lactitol) for the Treatment of Chronic Idiopathic Constipation in Adults

Sarclisa (isatuximab-irfc) Injection

Date of Approval: March 2, 2020
Company: Sanofi
Treatment for: Multiple Myeloma
Sarclisa (isatuximab-irfc) is a CD38-directed cytolytic antibody indicated in combination with pomalidomide and dexamethasone for the treatment of adult patients multiple myeloma. FDA Approves Sarclisa (isatuximab-irfc) for Patients with Relapsed Refractory Multiple Myeloma

Durysta (bimatoprost) Implant

Date of Approval: March 3, 2020
Company: Allergan plc
Treatment for: Glaucoma (Open Angle), Intraocular Hypertension
Durysta (bimatoprost implant) is a prostaglandin analog indicated for the reduction of intraocular pressure (IOP) in patients with open angle glaucoma (OAG) or ocular hypertension (OHT). FDA Approves Durysta (bimatoprost implant) to Lower Intraocular Pressure In Open-Angle Glaucoma or Ocular Hypertension Patients

Isturisa (osilodrostat) Tablets

Date of Approval: March 6, 2020
Company: Novartis Pharmaceuticals Corporation
Treatment for: Cushing's Syndrome
Isturisa (osilodrostat) is a cortisol synthesis inhibitor indicated for the treatment of adult patients with Cushing’s disease. FDA Approves Isturisa (osilodrostat) for the Treatment of Cushing’s Disease

Zeposia (ozanimod) Capsules

Date of Approval: March 25, 2020
Company: Bristol-Myers Squibb Company
Treatment for: Multiple Sclerosis
Zeposia (ozanimod) is a sphingosine 1-phosphate receptor modulator indicated for the treatment of relapsing forms of multiple sclerosis (MS). FDA Approves Zeposia (ozanimod) for Relapsing Forms of Multiple Sclerosis

Sevenfact (coagulation factor VIIa (recombinant)-jncw) Injection

Date of Approval: April 1, 2020
Company: HEMA Biologics, LLC
Treatment for: Hemophilia A or B with Inhibitors
Sevenfact (coagulation factor VIIa [recombinant]-jncw) is a coagulation factor VIIa concentrate indicated for the treatment and control of bleeding episodes occurring in adults and adolescents 12 years of age and older with hemophilia A or B with inhibitors (neutralizing antibodies). FDA Approves Sevenfact [coagulation factor VIIa (recombinant)-jncw] for Treatment and Control of Bleeding Episodes Occurring in Adult and Adolescent Hemophilia A and B Patients with Inhibitors

Koselugo (selumetinib) Capsules

Date of Approval: April 10, 2020
Company: AstraZeneca and Merck
Treatment for: Neurofibromatosis Type 1
Koselugo (selumetinib) is an inhibitor of mitogen-activated protein kinase kinases 1 and 2 (MEK1/2) indicated for the treatment of pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN). FDA Approves Koselugo (selumetinib) for Pediatric Patients with Neurofibromatosis Type 1 Plexiform Neurofibromas

Jelmyto (mitomycin) for Pyelocalyceal Solution

Date of Approval: April 15, 2020
Company: UroGen Pharma Ltd.
Treatment for: Urothelial Carcinoma
Jelmyto (mitomycin) is a novel formulation of the approved alkylating drug mitomycin for the treatment of patients with low-grade upper tract urothelial cancer (LG-UTUC). FDA Approves Jelmyto (mitomycin) for Treatment of Low-Grade Upper Tract Urothelial Cancer

Tukysa (tucatinib) Tablets

Date of Approval: April 17, 2020
Company: Seattle Genetics, Inc.
Treatment for: Breast Cancer
Tukysa (tucatinib) is a kinase inhibitor indicated in combination with trastuzumab and capecitabine for the treatment of patients with advanced unresectable or metastatic HER2-positive breast cancer. FDA Approves Tukysa (tucatinib) for People with Advanced Unresectable or Metastatic HER2-Positive Breast Cancer

Pemazyre (pemigatinib) Tablets

Date of Approval: April 17, 2020
Company: Incyte Corporation
Treatment for: Cholangiocarcinoma
Pemazyre (pemigatinib) is a selective fibroblast growth factor receptor (FGFR) inhibitor for the treatment of locally advanced or metastatic cholangiocarcinoma with FGFR2 fusions or rearrangements, as detected by an FDA-approved test. FDA Approves Pemazyre (pemigatinib) as First Targeted Treatment for Adults with Previously Treated, Unresectable Locally Advanced or Metastatic Cholangiocarcinoma

Emerphed (ephedrine sulfate) Injection

Date of Approval: April 17, 2020
Company: Nexus Pharmaceuticals, Inc.
Treatment for: Hypotension
Emerphed (ephedrine sulfate) is a ready-to-use formulation of the approved pressor agent ephedrine indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia. FDA Approves Emerphed (ephedrine sulfate) Ready-to-Use Injection for Hypotension During Anesthesia

Trodelvy (sacituzumab govitecan-hziy) Injection

Date of Approval: April 22, 2020
Company: Immunomedics, Inc.
Treatment for: Breast Cancer
Trodelvy (sacituzumab govitecan-hziy) is a Trop-2-directed antibody and topoisomerase inhibitor conjugate for the treatment of patients with previously-treated metastatic triple-negative breast cancer (mTNBC). FDA Approves Trodelvy (sacituzumab govitecan-hziy) for Previously-Treated Metastatic Triple Negative Breast Cancer

MenQuadfi (meningococcal (groups A, C, Y, W) conjugate vaccine) Injection

Date of Approval: April 23, 2020
Company: Sanofi
Treatment for: Meningococcal Meningitis Prophylaxis
MenQuadfi (meningococcal (groups A, C, Y, W) conjugate vaccine) is a MenACWY vaccine indicated for active immunization for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W, and Y in individuals 2 years of age and older. FDA Approves MenQuadfi (Meningococcal (Groups A, C, Y, W) Conjugate Vaccine) for Meningococcal (MenACWY) Vaccination

Ongentys (opicapone) Capsules

Date of Approval: April 24, 2020
Company: Neurocrine Biosciences, Inc.
Treatment for: Parkinson's Disease
Ongentys (opicapone) is a catechol-O-methyltransferase (COMT) inhibitor indicated as an adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease (PD) experiencing “off” episodes. FDA Approves Ongentys (opicapone) as an Add-On Treatment for Patients with Parkinson’s Disease Experiencing “Off” Episodes

Darzalex Faspro (daratumumab and hyaluronidase-fihj) Injection

Date of Approval: May 1, 2020
Company: The Janssen Pharmaceutical Companies of Johnson & Johnson
Treatment for: Multiple Myeloma
Darzalex Faspro (daratumumab and hyaluronidase-fihj) is a combination of daratumumab, a CD38-directed cytolytic antibody, and hyaluronidase, an endoglycosidase indicated for the treatment of adult patients with multiple myeloma. FDA Approves Darzalex Faspro (daratumumab and hyaluronidase-fihj) for the Treatment of Patients with Multiple Myeloma

Fensolvi (leuprolide acetate) Injection

Date of Approval: May 1, 2020
Company: Tolmar Pharmaceuticals, Inc.
Treatment for: Precocious Puberty
Fensolvi (leuprolide acetate) is a gonadotropin releasing hormone (GnRH) agonist indicated for the treatment of pediatric patients 2 years of age and older with central precocious puberty. FDA Approves Fensolvi (leuprolide acetate) for Injectable Suspension for Pediatric Patients with Central Precocious Puberty

Elyxyb (celecoxib) Oral Solution

Date of Approval: May 5, 2020
Company: Dr. Reddy’s Laboratories Limited
Treatment for: Migraine
Elyxyb (celecoxib) is an oral solution formulation of the nonsteroidal anti-inflammatory drug celecoxib (first approved under the brand name Celebrex) indicated for the acute treatment of migraine with or without aura in adults. FDA Approves Elyxyb (celecoxib) Oral Solution For Acute Treatment Of Migraine With Or Without Aura In Adults

Darzalex Faspro (daratumumab and hyaluronidase-fihj) Injection

Date of Approval: May 1, 2020
Company: The Janssen Pharmaceutical Companies of Johnson & Johnson
Treatment for: Multiple Myeloma
Darzalex Faspro (daratumumab and hyaluronidase-fihj) is a combination of daratumumab, a CD38-directed cytolytic antibody, and hyaluronidase, an endoglycosidase indicated for the treatment of adult patients with multiple myeloma. FDA Approves Darzalex Faspro (daratumumab and hyaluronidase-fihj) for the Treatment of Patients with Multiple Myeloma

Fensolvi (leuprolide acetate) Injection

Date of Approval: May 1, 2020
Company: Tolmar Pharmaceuticals, Inc.
Treatment for: Precocious Puberty
Fensolvi (leuprolide acetate) is a gonadotropin releasing hormone (GnRH) agonist indicated for the treatment of pediatric patients 2 years of age and older with central precocious puberty.

Elyxyb (celecoxib) Oral Solution

Date of Approval: May 5, 2020
Company: Dr. Reddy’s Laboratories Limited
Treatment for: Migraine
Elyxyb (celecoxib) is an oral solution formulation of the nonsteroidal anti-inflammatory drug celecoxib (first approved under the brand name Celebrex) indicated for the acute treatment of migraine with or without aura in adults. FDA Approves Elyxyb (celecoxib) Oral Solution For Acute Treatment Of Migraine With Or Without Aura In Adults

Tabrecta (capmatinib) Tablets

Date of Approval: May 6, 2020
Company: Novartis
Treatment for: Non-Small Cell Lung Cancer
Tabrecta (capmatinib) is a kinase inhibitor indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test. FDA Approves Tabrecta (capmatinib) for Metastatic Non-Small Cell Lung Cancer with METex14

Retevmo (selpercatinib) Capsules

Date of Approval: May 8, 2020
Company: Eli Lilly and Company
Treatment for: Non-Small Cell Lung Cancer, Thyroid Cancer
Retevmo (selpercatinib) is a kinase inhibitor for the treatment of patients with advanced RET fusion-positive non-small cell lung cancer (NSCLC), RET-mutant medullary thyroid cancer (MTC) and RET fusion-positive thyroid cancer. FDA Approves Retevmo (selpercatinib) for Patients with Advanced RET-Driven Lung and Thyroid Cancers

Qinlock (ripretinib) Tablets

Date of Approval: May 15, 2020
Company: Deciphera Pharmaceuticals, Inc.
Treatment for: Gastrointestinal Stromal Tumor
Qinlock (ripretinib) is a broad-spectrum KIT and PDGFRα inhibitor for the treatment of patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib. FDA Approves Qinlock (ripretinib) for the Treatment of Fourth-Line Gastrointestinal Stromal Tumor

Kynmobi (apomorphine hydrochloride) Sublingual Film

Date of Approval: May 21, 2020
Company: Sunovion Pharmaceuticals Inc.
Treatment for: Parkinson's Disease
Kynmobi (apomorphine sublingual film) is a novel formulation of the approved dopamine agonist apomorphine for the on-demand management of OFF episodes associated with Parkinson’s disease (PD). FDA Approves Kynmobi (apomorphine hydrochloride) Sublingual Film for the Treatment of Parkinson’s Disease OFF Episodes

Phexxi (lactic acid, citric acid and potassium bitartrate) Vaginal Gel - formerly Amphora

Date of Approval: May 22, 2020
Company: Evofem, Inc.
Treatment for: Contraception
Phexxi (lactic acid, citric acid and potassium bitartrate) is a non-hormonal vaginal gel indicated for the prevention of pregnancy in females of reproductive potential for use as an on-demand method of contraception. FDA Approves Phexxi (lactic acid, citric acid and potassium bitartrate) Non-Hormonal Prescription Gel for the Prevention of Pregnancy

(artesunate) for Injection

Date of Approval: May 26, 2020
Company: Amivas (US), LLC
Treatment for: Malaria
Artesunate for Injection is an antimalarial indicated for the initial treatment of severe malaria in adult and pediatric patients. Treatment of severe malaria with Artesunate for Injection should always be followed by a complete treatment course of an appropriate oral antimalarial regimen. FDA Approves Artesunate for Injection for the Treatment of Severe Malaria

Cardiology/Vascular Diseases

Vyndaqel (tafamidis meglumine) and Vyndamax (tafamidis) ; FoldRx Pharmaceuticals; For the treatment of cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis, Approved May 2019

Dermatology

Duobrii (halobetasol propionate and tazarotene) ; Ortho Dermatologics; For the treatment of plaque psoriasis , Approved April 2019 Jeuveau (prabotulinumtoxinA-xvfs); Evolus; For the improvement of glabellar lines, Approved February 2019 Skyrizi (risankizumab-rzaa) ; AbbVie; For the treatment of plaque psoriasis, Approved April 2019

Endocrinology

Jatenzo (testosterone undecanoate); Clarus Therapeutics; For the treatment of male conditions associated with a deficiency or absence of endogenous testosterone , Approved March 2019

Family Medicine

Tosymra (sumatriptan) nasal spray; Dr. Reddy's Labs; For the treatment of acute migraine in adults, Approved January 2019

Genetic Disease

Esperoct [antihemophilic factor (recombinant), glycopegylated-exei]; Novo Nordisk; For the treatment of hemophilia A, Approved February 2019 Vyndaqel (tafamidis meglumine) and Vyndamax (tafamidis) ; FoldRx Pharmaceuticals; For the treatment of cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis, Approved May 2019 Zolgensma (onasemnogene abeparvovec-xioi) ; Avexis; For the treatment of pediatrics. 2 years of age with spinal muscular atrophy with bi-allelic mutations in the SMN1 gene, Approved May 2019

Hematology

Cablivi (caplacizumab-yhdp); Ablynx; For the treatment of acquired thrombotic thrombocytopenic purpura, Approved February 2019 Esperoct [antihemophilic factor (recombinant), glycopegylated-exei]; Novo Nordisk; For the treatment of hemophilia A, Approved February 2019 Venclexta (venetoclax) plus Gazyva (obinutuzumab); Genentech and AbbVie; For the treatment of chronic lymphocytic leukemia or small lymphocytic lymphoma , Approved May 2019

Hepatology (Liver, Pancreatic, Gall Bladder)

Cyramza (ramucirumab) ; Eli Lilly; For the treatment of hepatocellular carcinoma with elevated alpha-fetoprotein (AFP), Approved May 2019 Egaten (triclabendazole); Novartis; For the treatment of fascioliasis (liver fluke infestation), Approved February 2019

Immunology

Asceniv (Immune Globulin Intravenous, Human – slra 10% Liquid); ADMA Biologics; For the treatment of Primary Humoral Immunodeficiency Disease , Approved April 2019 Dovato (dolutegravir and lamivudine) ; ViiV Healthcare; For the treatment of HIV-1 infection in adults, Approved April 2019 Ruzurgi (amifampridine); Jacobus Pharmaceuticals; For the treatment of Lambert-Eaton myasthenic syndrome in pediatrics, Approved May 2019

Infections and Infectious Diseases

Dengvaxia (Dengue Tetravalent Vaccine, Live) ; sanofi pasteur; For the prevention of dengue disease, Approved May 2019 Dovato (dolutegravir and lamivudine) ; ViiV Healthcare; For the treatment of HIV-1 infection in adults, Approved April 2019 Egaten (triclabendazole); Novartis; For the treatment of fascioliasis (liver fluke infestation), Approved February 2019 Jakafi (ruxolitinib); Incyte; For the treatment of steroid-refractory acute graft-versus-host disease in adults and pediatrics >12 years , Approved May 2019

Musculoskeletal

Cimzia (certolizumab pegol); UCB; For the treatment of non-radiographic axial spondyloarthritis, Approved March 2019 Evenity (romosozumab-aqqg); Amgen; For the treatment of osteoporosis in postmenopausal women at high risk for fracture, Approved April 2019 Mavenclad (cladribine) ; Merck; For the treatment of relapsing multiple sclerosis, Approved March 2019 Mayzent (siponimod); Novartis; For the treatment of relapsing multiple sclerosis, Approved March 2019 Ruzurgi (amifampridine); Jacobus Pharmaceuticals; For the treatment of Lambert-Eaton myasthenic syndrome in pediatrics, Approved May 2019 Zolgensma (onasemnogene abeparvovec-xioi) ; Avexis; For the treatment of pediatrics. 2 years of age with spinal muscular atrophy with bi-allelic mutations in the SMN1 gene, Approved May 2019

Nephrology

Bavencio (avelumab) plus Inlyta (axitinib) ; Merck and Pfizer; For the first line treatment of advanced renal cell carcinoma, Approved May 2019 Keytruda (pembrolizumab); Merck; For the treatment of advanced renal cell carcinoma, Approved April 2019

Neurology

Mavenclad (cladribine) ; Merck; For the treatment of relapsing multiple sclerosis, Approved March 2019 Mayzent (siponimod); Novartis; For the treatment of relapsing multiple sclerosis, Approved March 2019 Nayzilam (midazolam); UCB; For the treatment of intermittent, stereotypic episodes of frequent seizure activity, Approved May 2019 Ruzurgi (amifampridine); Jacobus Pharmaceuticals; For the treatment of Lambert-Eaton myasthenic syndrome in pediatrics, Approved May 2019 Spravato (esketamine) nasal spray; Janssen Pharmaceuticals; For the treatment of treatment-resistant depression in adults, Approved March 2019 Sunosi (solriamfetol) ; Jazz Pharmaceuticals; For the treatment of excessive daytime sleepiness due to narcolepsy or obstructive sleep apnea, Approved March 2019 Tosymra (sumatriptan) nasal spray; Dr. Reddy's Labs; For the treatment of acute migraine in adults, Approved January 2019

Obstetrics/Gynecology (Women’s Health)

Evenity (romosozumab-aqqg); Amgen; For the treatment of osteoporosis in postmenopausal women at high risk for fracture, Approved April 2019 Herceptin Hylecta (trastuzumab and hyaluronidase-oysk); Halozyme; For the treatment of HER2-overexpressing breast cancer, Approved February 2019 Piqray (alpelisib) ; Novartis; For the treatment of HR+, HER2-negative, PIK3CA-mutated advanced or metastatic breast cancer, Approved May 2019 Tecentriq (atezolizumab); Genentech/Roche; For the treatment of triple negative breast cancer, Approved March 2019 Zulresso (brexanolone); Sage Therapeutics; For the treatment of postpartum depression, Approved March 2019

Oncology

Balversa (erdafitinib); Janssen Oncology; For the treatment of locally advanced or metastatic urothelial carcinoma , Approved April 2019 Bavencio (avelumab) plus Inlyta (axitinib) ; Merck and Pfizer; For the first line treatment of advanced renal cell carcinoma, Approved May 2019 Cyramza (ramucirumab) ; Eli Lilly; For the treatment of hepatocellular carcinoma with elevated alpha-fetoprotein (AFP), Approved May 2019 Herceptin Hylecta (trastuzumab and hyaluronidase-oysk); Halozyme; For the treatment of HER2-overexpressing breast cancer, Approved February 2019 Keytruda (pembrolizumab); Merck; For the treatment of advanced renal cell carcinoma, Approved April 2019 Keytruda (pembrolizumab); Merck; For the treatment of stage III non-small cell lung cancer, Approved April 2019 Piqray (alpelisib) ; Novartis; For the treatment of HR+, HER2-negative, PIK3CA-mutated advanced or metastatic breast cancer, Approved May 2019 Tecentriq (atezolizumab); Genentech/Roche; For the treatment of extensive-stage small cell lung cancer , Approved March 2019 Tecentriq (atezolizumab); Genentech/Roche; For the treatment of triple negative breast cancer, Approved March 2019 Venclexta (venetoclax) plus Gazyva (obinutuzumab); Genentech and AbbVie; For the treatment of chronic lymphocytic leukemia or small lymphocytic lymphoma , Approved May 2019

Ophthalmology

Rocklatan (netarsudil and latanoprost ophthalmic solution); Aerie Pharmaceuticals; For the treatment of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension, Approved March 2019

Pediatrics/Neonatology

Nayzilam (midazolam); UCB; For the treatment of intermittent, stereotypic episodes of frequent seizure activity, Approved May 2019 Ruzurgi (amifampridine); Jacobus Pharmaceuticals; For the treatment of Lambert-Eaton myasthenic syndrome in pediatrics, Approved May 2019 Zolgensma (onasemnogene abeparvovec-xioi) ; Avexis; For the treatment of pediatrics

Psychiatry/Psychology

Spravato (esketamine) nasal spray; Janssen Pharmaceuticals; For the treatment of treatment-resistant depression in adults, Approved March 2019 Zulresso (brexanolone); Sage Therapeutics; For the treatment of postpartum depression, Approved March 2019

Pulmonary/Respiratory Diseases

Duaklir Pressair (aclidinium bromide and formoterol fumarate) ; Circassia Pharmaceuticals; For the maintenance treatment of chronic obstructive pulmonary disease, Approved April 2019 Keytruda (pembrolizumab); Merck; For the treatment of stage III non-small cell lung cancer, Approved April 2019 Sunosi (solriamfetol); Jazz Pharmaceuticals; For the treatment of excessive daytime sleepiness due to narcolepsy or obstructive sleep apnea, Approved March 2019 Tecentriq (atezolizumab); Genentech/Roche; For the treatment of extensive-stage small cell lung cancer , Approved March 2019

Rheumatology

Cimzia (certolizumab pegol); UCB; For the treatment of non-radiographic axial spondyloarthritis, Approved March 2019

Urology

Balversa (erdafitinib); Janssen Oncology; For the treatment of locally advanced or metastatic urothelial carcinoma , Approved April 2019

Jatenzo (testosterone undecanoate); Clarus Therapeutics; For the treatment of male conditions associated with a deficiency or absence of endogenous testosterone , Approved March 2019

Vaccines

Dengvaxia (Dengue Tetravalent Vaccine, Live) ; sanofi pasteur; For the prevention of dengue disease, Approved May 2019

Gastroenterology

Lutathera (lutetium Lu 177 dotatate); Advanced Accelerator Applications; For the treatment of gastroenteropancreatic neuroendocrine tumors, Approved January 2018

Infections and Infectious Diseases

Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide); Gilead; For the treatment of HIV-1 infection in adults, Approved February 2018

Oncology

Erleada (apalutamide); Janssen Oncology; For the treatment of prostate cancer, Approved February 2018 Lutathera (lutetium Lu 177 dotatate); Advanced Accelerator Applications; For the treatment of gastroenteropancreatic neuroendocrine tumors, Approved January 2018

Pulmonary/Respiratory Diseases

Symdeko (tezacaftor/ivacaftor) ; Vertex; For the treatment of cystic fibrosis , Approved February 2018

Urology

Erleada (apalutamide); Janssen Oncology; For the treatment of prostate cancer, Approved February 2018

Cardiology/Vascular Diseases


Bevyxxa (betrixaban); Portola Pharmaceuticals; For the the prophylaxis of venous thromboembolism, Approved June 2017

Dermatology


Bavencio (avelumab) ; EMD Serono/Pfizer; For the treatment of Merkel cell carcinoma , Approved March 2017
Baxdela (delafloxacin) tablets and injection; Melinta Therapeutics; For the treatment of acute bacterial skin and skin structure infections, Approved June 2017
Dupixent (dupilumab); Regeneron Pharmaceuticals; For the treatment of atopic dermatitis, Approved March 2017
Eskata (hydrogen peroxide); Aclaris Therapeutics; For the treatment of seborrheic keratoses, Approved December 2017
Rhofade (oxymetazoline hydrochloride); Allergan; For the treatment of facial erythema associated with rosacea, Approved January 2017
Siliq (brodalumab); Valeant Pharmaceuticals; For the treatment of plaque psoriasis , Approved February 2017
Tremfya (guselkumab); Janssen Biotech; For the treatment of moderate-to-severe plaque psoriasis, Approved July 2017
Xepi (ozenoxacin) ; Medimetriks; For the treatment of impetigo, Approved December 2017

Endocrinology


Macrilen (macimorelin); Stonebridge Biopharma; For the diagnosis of adult growth hormone deficiency , Approved December 2017
Ozempic (semaglutide); Novo Nordisk; For the treatment of type II diabetes, Approved December 2017
Parsabiv (etelcalcetide); Amgen; For the treatment of secondary hyperparathyroidism in adults with chronic kidney disease on hemodialysis, Approved February 2017
Qtern (dapagliflozin and saxagliptin) ; AstraZeneca; For the treatment of inadequately controlled type II diabetes , Approved February 2017
Steglatro (ertugliflozin); Merck; For the treatment of type 2 diabetes mellitus, Approved December 2017

Family Medicine


Ozempic (semaglutide); Novo Nordisk; For the treatment of type II diabetes, Approved December 2017
Qtern (dapagliflozin and saxagliptin) ; AstraZeneca; For the treatment of inadequately controlled type II diabetes , Approved February 2017
Steglatro (ertugliflozin); Merck; For the treatment of type 2 diabetes mellitus, Approved December 2017
Trulance (plecanatide); Synergy Pharmaceuticals; For the treatment of adults with chronic idiopathic constipation, Approved January 2017

Gastroenterology


Symproic (naldemedine); Shionogi; For the treatment of opioid-induced constipation, Approved March 2017
Trulance (plecanatide); Synergy Pharmaceuticals; For the treatment of adults with chronic idiopathic constipation, Approved January 2017
Xermelo (telotristat ethyl); Lexicon Pharmaceuticals; For the treatment of carcinoid syndrome diarrhea, Approved February 2017

Genetic Disease


Haegarda (C1 Esterase Inhibitor Subcutaneous [Human]) ; CSL Behring; For the routine prophylaxis to prevent Hereditary Angioedema attacks, Approved June 2017
Brineura (cerliponase alfa); BioMarin; For the treatment of late infantile neuronal ceroid lipofuscinosis type 2 , Approved April 2017
Mepsevii (vestronidase alfa-vjbk) ; Ultragenyx; For the treatment of Mucopolysaccharidosis VII , Approved November 2017

Hematology


Aliqopa (copanlisib); Bayer; For the treatment of follicular lymphoma , Approved September 2017
Besponsa (inotuzumab ozogamicin); Pfizer; For the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia, Approved August 2017
Calquence (acalabrutinib); Acerta Pharmaceuticals; For the treatment of mantle cell lymphoma , Approved November 2017
Endari (L-glutamine oral powder); Emmaus Life Sciences; For the treatment of sickle cell disease , Approved July 2017
Giapreza (angiotensin II) ; La Jolla Pharmaceuticals; For the treatment of septic shock, Approved December 2017
Hemlibra (emicizumab-kxwh); Genentech; For the prevention or reduction of bleeding episodes in patients with hemophilia A , Approved November 2017
IDHIFA (enasidenib); Celgene; For the treatment of relapsed or refractory acute myeloid leukemia with IDH2 mutation , Approved August 2017
Kymriah (tisagenlecleucel); Novartis; For the treatment of refractory B-cell precursor acute lymphoblastic leukemia , Approved August 2017
Rebinyn (Coagulation Factor IX (Recombinant), GlycoPEGylated) ; Novo Nordisk; For the treatment of hemophilia B, Approved June 2017
Rydapt (midostaurin); Novartis; For the treatment of FLT3 positive acute myeloid leukemia and mastocytosis , Approved April 2017
Vyxeos (daunorubicin and cytarabine) ; Jazz Pharma; For the treatment of newly-diagnosed therapy-related AML or AML with myelodysplasia-related changes, Approved August 2017
Yescarta (axicabtagene ciloleucel); Kite Pharmaceuticals; For the treatment of relapsed or refractory large B-cell lymphomas, Approved October 2017
Hepatology (Liver, Pancreatic, Gall Bladder)
Heplisav-B [Hepatitis B Vaccine (Recombinant), Adjuvanted] ; Dynavax; For the prevention of hepatitis B virus infection, Approved November 2017
Mavyret (glecaprevir and pibrentasvir) ; AbbVie; For the treatment of chronic HCV genotype 1, 2, 3, 4, 5 or 6, Approved August 2017
Vosevi (sofosbuvir, velpatasvir, and voxilaprevir) ; Gilead; For the treatment of hepatitis C, Approved July 2017

Immunology


Haegarda (C1 Esterase Inhibitor Subcutaneous [Human]) ; CSL Behring; For the routine prophylaxis to prevent Hereditary Angioedema attacks, Approved June 2017
Actemra (tocilizumab) injection; Genentech; For the treatment of CAR T cell-induced severe or life-threatening cytokine release syndrome, Approved September 2017
Ocrevus (ocrelizumab); Genentech; For the treatment of multiple sclerosis, Approved March 2017
Tremfya (guselkumab); Janssen Biotech; For the treatment of moderate-to-severe plaque psoriasis, Approved July 2017
Vosevi (sofosbuvir, velpatasvir, and voxilaprevir) ; Gilead; For the treatment of hepatitis C, Approved July 2017
Zerviate (cetirizine ophthalmic solution 0.24%); NicOx; For the treatment of ocular itching associated with allergic conjunctivitis, Approved May 2017

Infections and Infectious Diseases


Baxdela (delafloxacin) tablets and injection; Melinta Therapeutics; For the treatment of acute bacterial skin and skin structure infections, Approved June 2017
Benznidazole; Chemo Group; For the treatment of Chagas disease , Approved August 2017
Giapreza (angiotensin II) ; La Jolla Pharmaceuticals; For the treatment of septic shock, Approved December 2017
Heplisav-B [Hepatitis B Vaccine (Recombinant), Adjuvanted] ; Dynavax; For the prevention of hepatitis B virus infection, Approved November 2017
Juluca (dolutegravir and rilpivirine); ViiV Healthcare; For the treatment of HIV-1 infection in adults, Approved November 2017
KedRab [Rabies Immune Globulin (Human)]; Kedrion Biopharma ; For the post-exposure prophylaxis of rabies infection, Approved August 2017
Mavyret (glecaprevir and pibrentasvir) ; AbbVie; For the treatment of chronic HCV genotype 1, 2, 3, 4, 5 or 6, Approved August 2017
Prevymis (letermovir) ; Merck; For the prevention of cytomegalovirus following allogenic hematopoietic stem cell transplant, Approved November 2017
Shingrix (Zoster Vaccine Recombinant, Adjuvanted) ; GlaxoSmithKline; For the prevention of herpes zoster (shingles), Approved October 2017
Solosec (secnidazole) ; Symbiomix Therapeutics; For the treatment of bacterial vaginosis , Approved September 2017
Vabomere (meropenem and vaborbactam); The Medicines Company; For the treatment of complicated urinary tract infections , Approved August 2017
Xepi (ozenoxacin) ; Medimetriks; For the treatment of impetigo, Approved December 2017

Internal Medicine


Duzallo (lesinurad and allopurinol) ; Ardea Biosciences; For the treatment of hyperuricemia associated with gout , Approved August 2017

Musculoskeletal


Brineura (cerliponase alfa); BioMarin; For the treatment of late infantile neuronal ceroid lipofuscinosis type 2 , Approved April 2017
Duzallo (lesinurad and allopurinol) ; Ardea Biosciences; For the treatment of hyperuricemia associated with gout , Approved August 2017
Emflaza (deflazacort); Marathon Pharmaceuticals; For the treatment of Duchenne muscular dystrophy, Approved February 2017
Kevzara (sarilumab); Sanofi ; For the treatment of active rheumatoid arthritis, Approved May 2017
Ocrevus (ocrelizumab); Genentech; For the treatment of multiple sclerosis, Approved March 2017
Tymlos (abaloparatide) ; Radius Health; For the treatment of postmenopausal women with osteoporosis at high risk for fracture, Approved April 2017
Zilretta (triamcinolone acetonide extended-release injectable suspension); Flexion Therapeutics; For the treatment of osteoarthritis knee pain, Approved October 2017

Nephrology


Parsabiv (etelcalcetide); Amgen; For the treatment of secondary hyperparathyroidism in adults with chronic kidney disease on hemodialysis, Approved February 2017

Neurology


Austedo (deutetrabenazine) ; Teva Pharmaceuticals; For the treatment of chorea associated with Huntington’s disease and tardive dyskinesia , Initial approval April 2017
Brineura (cerliponase alfa); BioMarin; For the treatment of late infantile neuronal ceroid lipofuscinosis type 2 , Approved April 2017
Gocovri (amantadine) ; Adamas Pharmaceuticals; For the treatment of Parkinson's disease dyskinesia, Approved August 2017
Ingrezza (valbenazine); Neurocrine Biosciences; For the treatment of tardive dyskinesia, Approved April 2017
Radicava (edaravone); Mitsubishi Tanabe Pharma; For the treatment of amyotrophic lateral sclerosis , Approved May 2017
Xadago (safinamide); Newron Pharmaceuticals; For the treatment of Parkinson's disease, Approved March 2017

Obstetrics/Gynecology (Women’s Health)


Kisqali (ribociclib); Novartis; For the treatment of breast cancer, Approved March 2017
Solosec (secnidazole) ; Symbiomix Therapeutics; For the treatment of bacterial vaginosis , Approved September 2017
Tymlos (abaloparatide) ; Radius Health; For the treatment of postmenopausal women with osteoporosis at high risk for fracture, Approved April 2017
Verzenio (abemaciclib); Eli Lilly; For the treatment of HR+, HER2- breast cancer, Approved September 2017
Zejula (niraparib); Tesaro; For the treatment of recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer , Approved March 2017

Oncology


Aliqopa (copanlisib); Bayer; For the treatment of follicular lymphoma , Approved September 2017
Alunbrig (brigatinib); Ariad Pharmaceuticals; For the treatment of advanced ALK-positive metastatic non-small cell lung cancer, Approved April 2017
Bavencio (avelumab) ; EMD Serono/Pfizer; For the treatment of Merkel cell carcinoma , Approved March 2017
Besponsa (inotuzumab ozogamicin); Pfizer; For the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia, Approved August 2017
Calquence (acalabrutinib); Acerta Pharmaceuticals; For the treatment of mantle cell lymphoma , Approved November 2017
IDHIFA (enasidenib); Celgene; For the treatment of relapsed or refractory acute myeloid leukemia with IDH2 mutation , Approved August 2017
Imfinzi (durvalumab); AstraZeneca; For the treatment of advanced or metastatic urothelial carcinoma and Stage III non-small cell lung cancer, Initially approved May 2017
Kisqali (ribociclib); Novartis; For the treatment of breast cancer, Approved March 2017
Kymriah (tisagenlecleucel); Novartis; For the treatment of refractory B-cell precursor acute lymphoblastic leukemia , Approved August 2017
Nerlynx (neratinib); Puma Biotech; For the treatment of HER2 breast cancer, Approved July 2017
Rydapt (midostaurin); Novartis; For the treatment of FLT3 positive acute myeloid leukemia and mastocytosis , Approved April 2017
Verzenio (abemaciclib); Eli Lilly; For the treatment of HR+, HER2- breast cancer, Approved September 2017
Vyxeos (daunorubicin and cytarabine) ; Jazz Pharma; For the treatment of newly-diagnosed therapy-related AML or AML with myelodysplasia-related changes, Approved August 2017
Xermelo (telotristat ethyl); Lexicon Pharmaceuticals; For the treatment of carcinoid syndrome diarrhea, Approved February 2017
Yescarta (axicabtagene ciloleucel); Kite Pharmaceuticals; For the treatment of relapsed or refractory large B-cell lymphomas, Approved October 2017
Zejula (niraparib); Tesaro; For the treatment of recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer , Approved March 2017

Ophthalmology


Luxturna (voretigene neparvovec); Spark Therapeutics; For the treatment of vision loss due to confirmed biallelic RPE65-mediated inherited retinal disease, Approved December 2017
Rhopressa (netarsudil ophthalmic solution) ; Aerie Pharmaceuticals; For the treatment of glaucoma or ocular hypertension, Approved December 2017
Vyzulta (latanoprostene bunod ophthalmic solution); Bausch & Lomb; For the reduction of intraocular pressure in patients with open-angle glaucoma or ocular hypertension, Approved November 2017
Zerviate (cetirizine ophthalmic solution 0.24%); NicOx; For the treatment of ocular itching associated with allergic conjunctivitis, Approved May 2017

Pediatrics/Neonatology


Brineura (cerliponase alfa); BioMarin; For the treatment of late infantile neuronal ceroid lipofuscinosis type 2 , Approved April 2017
Emflaza (deflazacort); Marathon Pharmaceuticals; For the treatment of Duchenne muscular dystrophy, Approved February 2017
Rebinyn (Coagulation Factor IX (Recombinant), GlycoPEGylated) ; Novo Nordisk; For the treatment of hemophilia B, Approved June 2017

Pharmacology/Toxicology


Actemra (tocilizumab) injection; Genentech; For the treatment of CAR T cell-induced severe or life-threatening cytokine release syndrome, Approved September 2017
Gocovri (amantadine) ; Adamas Pharmaceuticals; For the treatment of Parkinson's disease dyskinesia, Approved August 2017

Pulmonary/Respiratory Diseases


Imfinzi (durvalumab); AstraZeneca; For the treatment of advanced or metastatic urothelial carcinoma and Stage III non-small cell lung cancer, Initially approved May 2017

Rheumatology


Duzallo (lesinurad and allopurinol) ; Ardea Biosciences; For the treatment of hyperuricemia associated with gout , Approved August 2017
Kevzara (sarilumab); Sanofi ; For the treatment of active rheumatoid arthritis, Approved May 2017
Zilretta (triamcinolone acetonide extended-release injectable suspension); Flexion Therapeutics; For the treatment of osteoarthritis knee pain, Approved October 2017

Urology


Imfinzi (durvalumab); AstraZeneca; For the treatment of advanced or metastatic urothelial carcinoma and Stage III non-small cell lung cancer, Initially approved May 2017
Vabomere (meropenem and vaborbactam); The Medicines Company; For the treatment of complicated urinary tract infections , Approved August 2017

Vaccines


Shingrix (Zoster Vaccine Recombinant, Adjuvanted) ; GlaxoSmithKline; For the prevention of herpes zoster (shingles), Approved October 2017

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