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FDA Approved Drugs

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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

Cardiology/Vascular Diseases


Byvalson (nebivolol and valsartan); Allergan; For the treatment of hypertension, Approved June 2016
Yosprala (aspirin and omeprazole); Aralez Pharmaceuticals; For the prevention of cardiovascular and cerebrovascular events, Approved September 2016

Dermatology


Ameluz (aminolevulinic acid hydrochloride); Biofrontera Pharma; For the treatment of actinic keratoses, Approved May 2016
Eucrisa (crisaborole) ointment; Pfizer; For the treatment of atopic dermatitis, Approved December 2016
Taltz (ixekizumab); Eli Lilly; For the treatment of plaque psoriasis and active psoriatic arthritis, Approved March 2016

Endocrinology


Adlyxin (lixisenatide); Sanofi Aventis; For the treatment of type II diabetes, Approved July 2016
Soliqua 100/33 (insulin glargine and lixisenatide injection); Sanofi Aventis; For the treatment of inadequately controlled type II diabetes, Approved November 2016
Xultophy 100/3.6 (insulin degludec and liraglutide injection); Novo Nordisk; For the treatment of inadequately controlled type II diabetes, Approved November 2016

Family Medicine


Byvalson (nebivolol and valsartan); Allergan; For the treatment of hypertension, Approved June 2016
Onzetra Xsail (sumatriptan nasal powder) ; Avanir; For the treatment of migraine, Approved January 2016
Soliqua 100/33 (insulin glargine and lixisenatide injection); Sanofi Aventis; For the treatment of inadequately controlled type II diabetes, Approved November 2016
Xultophy 100/3.6 (insulin degludec and liraglutide injection); Novo Nordisk; For the treatment of inadequately controlled type II diabetes, Approved November 2016

Gastroenterology


Zinplava (bezlotoxumab); Merck; For the treatment of recurrent Clostridium difficile infection in patients receiving antibacterial treatment, Approved October 2016

Genetic Disease


Spinraza (nusinersen); Biogen; For the treatment of spinal muscular atrophy, Approved December 2016

Hematology


Afstyla (Antihemophilic Factor (Recombinant), Single Chain); CSL Behring; For the treatment of hemophillia A, Approved May 2016
Idelvion (Coagulation Factor IX (Recombinant), Albumin Fusion Protein); CSL Behring; For the treatment of hemophilia B, Approved March 2016
Kovaltry [Antihemophilic Factor (Recombinant)]; Bayer ; For the treatment of hemophillia A, Approved March 2016
Opdivo (nivolumab); Bristol-Myers Squibb; For the treatment of classical Hodgkin lymphoma, Approved May 2016
Venclexta (venetoclax); AbbVie; For the treatment of chronic lymphocytic leukemia with 17p deletion, Approved April 2016

Hepatology (Liver, Pancreatic, Gall Bladder)


Defitelio (defibrotide sodium); Jazz Pharmaceuticals; For the treatment of hepatic veno-occlusive disease with renal or pulmonary dysfunction following HSCT, Approved March 2016
Ocaliva (obeticholic acid); Intercept Pharmaceuticals; For the treatment of primary biliary cholangitis, Approved May 2016
Vemlidy (tenofovir alafenamide); Gilead Sciences; For the treatment of chronic hepatitis B , Approved November 2016
Zepatier (elbasvir and grazoprevir); Merck; For the treatment of chronic HCV genotypes 1 or 4 , Approved January 2016

Immunology


Afstyla (Antihemophilic Factor (Recombinant), Single Chain); CSL Behring; For the treatment of hemophillia A, Approved May 2016
Descovy (emtricitabine and tenofovir alafenamide); Gilead; For the treatment of HIV-1 infection, Approved April 2016
Epclusa (sofosbuvir and velpatasvir) ; Gilead Sciences; For the treatment of hepatitis C, Approved June 2016
Odefsey (emtricitabine, rilpivirine, and tenofovir alafenamide); Gilead Sciences; For the treatment of HIV-1 as initial therapy, Approved March 2016
Taltz (ixekizumab); Eli Lilly; For the treatment of plaque psoriasis and active psoriatic arthritis, Approved March 2016
Vaxchora (Cholera Vaccine, Live, Oral); PaxVax; For active immunization against Cholera, Approved June 2016

Infections and Infectious Diseases


Anthim (obiltoxaximab); Elusys Therapeutics; For the treatment of inhalational anthrax , Approved March 2016
Descovy (emtricitabine and tenofovir alafenamide); Gilead; For the treatment of HIV-1 infection, Approved April 2016
Epclusa (sofosbuvir and velpatasvir) ; Gilead Sciences; For the treatment of hepatitis C, Approved June 2016
Odefsey (emtricitabine, rilpivirine, and tenofovir alafenamide); Gilead Sciences; For the treatment of HIV-1 as initial therapy, Approved March 2016
Syndros (dronabinol oral solution); Insys Therapeutics; For the treatment of anorexia associated with AIDS and nausea and vomiting associated with cancer chemotherapy, Approved July 2016
Vaxchora (Cholera Vaccine, Live, Oral); PaxVax; For active immunization against Cholera, Approved June 2016
Vemlidy (tenofovir alafenamide); Gilead Sciences; For the treatment of chronic hepatitis B , Approved November 2016
Zepatier (elbasvir and grazoprevir); Merck; For the treatment of chronic HCV genotypes 1 or 4 , Approved January 2016
Zinplava (bezlotoxumab); Merck; For the treatment of recurrent Clostridium difficile infection in patients receiving antibacterial treatment, Approved October 2016

Musculoskeletal


Exondys 51 (eteplirsen); Sarepta Therapeutics; For the treatment of Duchenne muscular dystrophy with mutated DMD gene amenable to exon 51 skipping, Approved September 2016
Spinraza (nusinersen); Biogen; For the treatment of spinal muscular atrophy, Approved December 2016
Zinbryta (daclizumab) ; Biogen; For the treatment of relapsing multiple sclerosis, Approved May 2016

Nephrology


Cabometyx (cabozantinib); Exelixis; For the treatment of advanced renal cell carcinoma, Approved April 2016
Lenvima (lenvatinib); Eisai; For the treatment of advanced renal cell carcinoma, Approved May 2016
Rayaldee (calcifediol) ; Opko Health; For the treatment of secondary hyperparathyroidism in adults with stage 3 or 4 chronic kidney disease, Approved June 2016

Neurology


Briviact (brivaracetam); UCB; For the treatment of partial onset seizures related to epilepsy, Approved February 2016
Carnexiv (carbamazepine); Lundbeck; replacement therapy when oral administration is not feasible, in adults with seizures, Approved October 2016
Exondys 51 (eteplirsen); Sarepta Therapeutics; For the treatment of Duchenne muscular dystrophy with mutated DMD gene amenable to exon 51 skipping, Approved September 2016
Nuplazid (pimavanserin); Acadia Pharmaceuticals; For the treatment of hallucinations and delusions associated with Parkinson’s disease, Approved April 2016
Nuplazid (pimavanserin); Acadia Pharmaceuticals; For the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis, Approved May 2016
Onzetra Xsail (sumatriptan nasal powder) ; Avanir; For the treatment of migraine, Approved January 2016
Spinraza (nusinersen); Biogen; For the treatment of spinal muscular atrophy, Approved December 2016
Troxyca ER (oxycodone + naltrexone); Pfizer; For the management of severe pain, Approved August 2016
Zinbryta (daclizumab) ; Biogen; For the treatment of relapsing multiple sclerosis, Approved May 2016

Obstetrics/Gynecology (Women’s Health)


Intrarosa (prasterone vaginal insert); Endoceutics; For the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause, Approved November 2016
Rubraca (rucaparib); Clovis Oncology; For the treatment of advanced ovarian cancer in women with deleterious germline or somatic BRCA mutation, Approved December 2016

Oncology


Cabometyx (cabozantinib); Exelixis; For the treatment of advanced renal cell carcinoma, Approved April 2016
Keytruda (pembrolizumab); Merck; For the treatment of head and neck squamous cell cancer , Approved August 2016
Lartruvo (olaratumab) ; Eli Lilly; For the treatment of soft tissue sarcoma, Approved October 2016
Lenvima (lenvatinib); Eisai; For the treatment of advanced renal cell carcinoma, Approved May 2016
Opdivo (nivolumab); Bristol-Myers Squibb; For the treatment of classical Hodgkin lymphoma, Approved May 2016
Opdivo (nivolumab); Bristol-Myers Squibb; For the treatment of recurrent or metastatic squamous cell carcinoma of the head and neck, Approved November 2016
Rubraca (rucaparib); Clovis Oncology; For the treatment of advanced ovarian cancer in women with deleterious germline or somatic BRCA mutation, Approved December 2016
Sustol (granisetron); Heron Therapeutics; For the prevention of chemotherapy-induced nausea and vomiting, Approved August 2016
Syndros (dronabinol oral solution); Insys Therapeutics; For the treatment of anorexia associated with AIDS and nausea and vomiting associated with cancer chemotherapy, Approved July 2016
Tecentriq (atezolizumab); Genentech; For the treatment of urothelial carcinoma and metastatic non-small cell lung cancer, Approved May 2016
Venclexta (venetoclax); AbbVie; For the treatment of chronic lymphocytic leukemia with 17p deletion, Approved April 2016

Ophthalmology


Humira (adalimumab); Abbvie; For the treatment of uveitis, Approved July 2016
Xiidra (lifitegrast); Shire; For the treatment of dry eye disease, Approved July 2016

Pediatrics/Neonatology


Exondys 51 (eteplirsen); Sarepta Therapeutics; For the treatment of Duchenne muscular dystrophy with mutated DMD gene amenable to exon 51 skipping, Approved September 2016
Kovaltry [Antihemophilic Factor (Recombinant)]; Bayer ; For the treatment of hemophillia A, Approved March 2016
Spinraza (nusinersen); Biogen; For the treatment of spinal muscular atrophy, Approved December 2016

Pharmacology/Toxicology


Sustol (granisetron); Heron Therapeutics; For the prevention of chemotherapy-induced nausea and vomiting, Approved August 2016

Psychiatry/Psychology


Nuplazid (pimavanserin); Acadia Pharmaceuticals; For the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis, Approved May 2016

Pulmonary/Respiratory Diseases


Bevespi Aerosphere (glycopyrrolate and formoterol fumarate); AstraZeneca; For the treatment of chronic obstructive pulmonary disease, Approved April 2016
Cinqair (reslizumab); Teva Pharmaceuticals; For the treatment of severe asthma, Approved March 2016
Tecentriq (atezolizumab); Genentech; For the treatment of urothelial carcinoma and metastatic non-small cell lung cancer, Approved May 2016

Rheumatology


Taltz (ixekizumab); Eli Lilly; For the treatment of plaque psoriasis and active psoriatic arthritis, Approved March 2016

Urology


Tecentriq (atezolizumab); Genentech; For the treatment of urothelial carcinoma and metastatic non-small cell lung cancer, Approved May 2016

Vaccines


Vaxchora (Cholera Vaccine, Live, Oral); PaxVax; For active immunization against Cholera, Approved June 2016