written on 18.12.2019

FDA Drugs Approved in 2019

In 2019, the US FDA’s Center for Drug Evaluation and Research approved 42 novel drugs, down from 59 drugs approved in 2018.

Novartis had four drugs approved, the highest number from any single pharma company.

16 of the 42, or 38 per cent, received orphan drug designation.

This listing does not contain vaccines, allergenic products, blood and blood products, plasma derivatives, cellular and gene therapy products, or other products approved in 2019 by the Center for Biologics Evaluation and Research.

See below for a full list of the approved drugs and read more at the FDA website.

       Drug Name Company Active Ingredient Approval Date FDA-Approved Use on Approval Date
1 Jeuveau Evolus Inc prabotulinumtoxinA-xvfs 2/1/2019 For the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients
2 Cablivi Ablynx NV caplacizumab-yhdp 2/6/2019 To treat adult patients with acquired thrombotic thrombocytopenic purpura (aTTP)
3 Egaten Novartis triclabendazole 2/13/2019 To treat fascioliasis, a parasitic infestation caused by two species of flatworms or trematodes that mainly the affect the liver, sometimes referred to as “liver flukes”
4 Zulresso Sage Therapeutics brexanolone 3/19/2019 To treat postpartum depression (PPD) in adult women
5 Sunosi Jazz Pharmaceuticals solriamfetol 3/20/2019 To treat excessive sleepiness in adult patients with narcolepsy or obstructive sleep apnea
6 Mayzent Novartis siponimod 3/26/2019 To treat adults with relapsing forms of multiple sclerosis
7 Evenity Amgen romosozumab-aqqg 4/9/2019 To treat osteoporosis in postmenopausal women at high risk of fracture
8 Balversa Janssen erdafitinib 4/12/2019 To treat adult patients with locally advanced or metastatic bladder cancer
9 Skyrizi AbbVie risankizumab-rzaa 4/23/2019 To treat moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy
10 Vyndaqel FoldRx Pharmaceuticals tafamidis meglumine 5/3/2019 To treat heart disease (cardiomyopathy) caused by transthyretin mediated amyloidosis (ATTR-CM) in adults

 

       Drug Name Company Active Ingredient Approval Date FDA-Approved Use on Approval Date
11 Piqray Novartis alpelisib 5/24/2019 To treat breast cancer
12 Polivy Genentech polatuzumab vedotin-piiq 6/10/2019 To treat adult patients with relapsed or refractory diffuse large B-cell lymphoma
13 Vyleesi AMAG Pharmaceuticals bremelanotide 6/21/2019 To treat hypoactive sexual desire disorder in premenopausal women.
14 Xpovio Karyopharm Therapeutics selinexor 7/3/2019 To treat adult patients with relapsed or refractory multiple myeloma (RRMM)
15 Recarbrio MSD imipenem, cilastatin and relebactam 7/16/2019 To treat complicated urinary tract and complicated intra-abdominal infections
16 Accrufer Shield ferric maltol 7/25/2019 To treat iron deficiency anemia in adults
17 Nubeqa Bayer darolutamide 7/30/2019 To treat adult patients with non-metastatic castration resistant prostate cancer
18 Turalio Daiichi Sankyo pexidartinib 8/2/2019 To treat adult patients with symptomatic tenosynovial giant cell tumor
19 Pretomanid Mylan pretomanid 8/14/2019 For treatment-resistant forms of tuberculosis that affects the lungs
20 Wakix Harmony Biosciences pitolisant 8/14/2019 To treat excessive daytime sleepiness (EDS) in adult patients with narcolepsy

 

       Drug Name Company Active Ingredient Approval Date FDA-Approved Use on Approval Date
21 Rozlytrek Genentech entrectinib 8/15/2019 To treat adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are ROS1-positive
To treat adult and pediatric patients 12 years of age and older with solid tumors
22 Inrebic Impact fedratinib 8/26/2019 To treat adult patients with intermediate-2 or high-risk primary or secondary myelofibrosis
23 Rinvoq AbbVie upadacitinib 8/16/2019 To treat adults with moderately to severely active rheumatoid arthritis
24 Xenleta Nabriva lefamulin 8/19/2019 To treat adults with community-acquired bacterial pneumonia
25 Gallium-68-DOTATOC UIHC PET Imaging Ga-68-DOTATOC 8/21/2019 For use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs)
26 Nourianz Kyowa Kirin istradefylline 8/27/2019 To treat adult patients with Parkinson’s disease experiencing “off” episodes
27 Ibsrela Ardelyx Inc tenapanor 9/12/2019 To treat irritable bowel syndrome with constipation in adults.
28 Aklief Galderma trifarotene 10/4/2019 For the topical treatment of acne vulgaris in patients 9 years of age and older
29 Beovu Novartis brolucizumab–dbll 10/7/2019 Treatment of wet age-related macular degeneration
30 Scenesse Clivunel Inc afamelanotide 10/8/2019 To increase pain-free light exposure in adult patients with a history of phototoxic reactions (damage to skin) from erythropoietic protoporphyria

 

       Drug Name Company Active Ingredient Approval Date FDA-Approved Use on Approval Date
31 Fluorodopa F 18 Feinstein fluorodopa F 18 10/10/2019 A diagnostic agent for use in positron emission tomography (PET) to help diagnose adult patients with suspected Parkinsonian syndromes (PS)
32 Reyvow Eli Lilly & Co lasmiditan 10/11/2019 For the acute treatment of migraine with or without aura, in adults
33 Trikafta Vertex Pharmaceuticals elexacaftor/ ivacaftor/ tezacaftor 10/21/2019 To treat patients 12 years of age and older with the most common gene mutation that causes cystic fibrosis
34 ExEm Foam GISKIT air polymer-type A 11/7/2019 A diagnostic agent used to assess fallopian tube patency (openness) in women with known or suspected infertility
35 Reblozyl Celgene luspatercept–aamt 11/8/2019 For the treatment of anemia in adult patients with beta thalassemia who require regular red blood cell transfusions
36 Brukinsa BeiGene zanubrutinib 11/14/2019 To treat certain patients with mantle cell lymphoma, a form of blood cancer
37 Fetroja Shionogi Inc cefiderocol 11/14/2019 To treat patients with complicated urinary tract infections who have limited or no alternative treatment options
38 Adakveo Novartis crizanlizumab-tmca 11/15/2019 To treat patients with painful complication of sickle cell disease
39 Givlaari Alnylam Pharmaceuticals givosiran 11/20/2019 To treat acute hepatic porphyria, a rare blood disorder
40 Xcopri SK Life Science Inc cenobamate 11/21/2019 To treat partial onset seizures
41 Oxbryta Global Blood Therapeutics voxelotor 11/25/2019 To treat sickle cell disease
42 Vyondys 53 Sarepta Therapeutics golodirsen 12/12/2019 To treat certain patients with Duchenne muscular dystrophy

Source: FDA.gov

Similar Facts and Figures

Latest Report