Innovation drives progress. Center for Drug Evaluation and Research (CDER) of FDA has been a strong supporter of innovation in the development of new drugs and biotherapy products. By understanding the mechanism of new product development, product screening and production processes, as well as the diseases and symptoms that drugs need to treat, CDER provides scientific and regulatory advices for products that are about to be brought to market. The production of new drugs and biological products means providing patients with new treatment options, which has greatly promoted progress in the field of health care.
This year, CDER approved a total of 41 new drugs, including diagnostic reagents, targeted drugs and antibiotics with new targets, such as Reyvow – the world’s first drug for acute migraine, Givlaari – the second RNAi drug, and Xenleta – a new kind of antibiotic.
| Drug Name | Trade Name | Company | Approval Date | |
| 1 | PrabotulinmtoxinA | Jeuveau | Evolus | 2019/2/1 |
| 2 | Caplacizumab-yhdp | Cablivi | Ablynx | 2019/2/6 |
| 3 | Triclabendazole | Egaten | Novartis | 2019/2/13 |
| 4 | Brexanolone | Zulress | Sage Therapeutics | 2019/3/19 |
| 5 | Solriamfetol | Sunosi | Jazz Pharmaceuticals | 2019/3/20 |
| 6 | Siponimod | Mayzent | Novartis | 2019/3/26 |
| 7 | Romosozumab-aqqg | Evenity | Amgen and UCB | 2019/4/9 |
| 8 | Erdafitinib | Balversa | Janssen Pharmaceutica | 2019/4/12 |
| 9 | Risankizumab | Skyrizi | AbbVie | 2019/4/23 |
| 10 | Tafamidis meglumine | Vyndaqel | Pfizer | 2019/5/3 |
| 11 | alpelisib | Piqray | Novartis | 2019/5/24 |
| 12 | Polatuzumab vedotin-piiq | Polivy | Roche | 2019/6/10 |
| 13 | Bremelanotide | Vyleesi | Palatin Technologies | 2019/6/21 |
| 14 | selinexor | Xpovio | Karyopharm Therapeutics | 2019/7/3 |
| 15 | Imipenem, cilastatin and relebactam | Recarbrio | Merck Sharp & Dohme | 2019/7/16 |
| 16 | Ferric maltol | Accrufer | Shield Therapeutics | 2019/7/25 |
| 17 | Darolutamide | Nubeqa | Bayer | 2019/7/30 |
| 18 | Pexidartinib | Turalio | Daiichi Sankyo | 2019/8/2 |
| 19 | Pretomanid | TB Alliance | 2019/8/14 | |
| 20 | pitolisant | Wakix | Bioprojet | 2019/8/14 |
| 21 | entrectinib | Rozlytrek | Genentech | 2019/8/15 |
| 22 | fedratinib | Inrebic | Celgene | 2019/8/16 |
| 23 | upadacitinib | Rinvoq | AbbVie | 2019/8/16 |
| 24 | lefamulin | Xenleta | Nabriva Therapeutics | 2019/8/19 |
| 25 | Ga-68-DOTATOC | Ga-68-DOTATOC | 2019/8/21 | |
| 26 | istradefylline | Nourianz | Kyowa Kirin | 2019/8/27 |
| 27 | tenapanor | Ibsrela | Ardelyx | 2019/9/12 |
| 28 | trifarotene | Aklief | Galderma | 2019/10/4 |
| 29 | brolucizumab–dbll | Beovu | Novartis | 2019/10/7 |
| 30 | afamelanotide | Scenesse | Clinuvel Pharmaceuticals | 2019/10/8 |
| 31 | fluorodopa F 18 | 2019/10/10 | ||
| 32 | lasmiditan | Reyvow | Lilly | 2019/10/11 |
| 33 | elexacaftor/ivacaftor/tezacaftor | Trikafta | Vertex | 2019/10/21 |
| 34 | air polymer-type A | ExEm Foam | 2019/11/7 | |
| 35 | luspatercept-aamt | Reblozyl | Celgene | 2019/11/8 |
| 36 | zanubrutinib | Brukinsa | BeiGene | 2019/11/14 |
| 37 | cefiderocol | Fetroja | Shionogi | 2019/11/14 |
| 38 | crizanlizumab | Adakveo | Novartis | 2019/11/15 |
| 39 | givosiran | Givlaari | Alnylam | 2019/11/20 |
| 40 | cenobamate | Xcopri | SK Life Sciences | 2019/11/21 |
| 41 | voxelotor | Oxbryta | Global Blood Therapeutics | 2019/11/25 |