FDA Approved Drugs

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