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
