48 New Novel Drugs Approved by the FDA in 2019

This is a list of new molecular entities and new therapeutic biological products approved by the agency’s Center for Biologics Evaluation and Research in 2019.

The U.S. Food and Drug Administration (FDA) oversees and approves a wide range of medical products each year. Many approvals are for previously approved drugs for new indications. Others are for new molecular entities and new therapeutic biological products. Below is a list of new molecular entities and new therapeutic biological products approved by the agency’s Center for Biologics Evaluation and Research in 2019. The list does not contain vaccines, allergenic products, blood and blood products, plasma derivatives, cellular and gene therapy products, or other products approved this year.

  1. Evolus’ Jeuveau (prabotulinumtoxinA-xvfs). For temporary improvement of moderate to severe glabellar lines (frown lines).
  2. Sanofi Genzyme’s Cablivi (caplacizumab-yhdtp). For adults with acquired thrombotic thrombocytopenic purpura (aTTP).
  3. Novartis’ Egaten (triclabendazole). For fascioliasis, a parasitic infestation caused by two types of flatworms.
  4. Sage Therapeutics’ Zulresso (brexanolone). For postpartum depression.
  5. Jazz Pharmaceuticals’ Sunosi (solriamfetol). For excessive sleepiness in adults with narcolepsy or obstructive sleep apnea.
  6. Novartis’ Mayzent (siponimod). For adults with relapsing forms of multiple sclerosis (MS).
  7. Amgen’s Evenity (romosozumab-aqqg). For osteoporosis in postmenopausal women at high risk of fracture.
  8. Janssen’s Balversa (erdafitinib). For adults with locally advanced or metastatic bladder cancer.
  9. AbbVie’s Skyrizi (risankizumab-rzaa). To treat moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
  10. Pfizer’s Vyndaqel (tafamidis meglumine). For heart disease caused by transthyretin mediated amyloidosis (ATTR-CM).
  11. Novartis’ Piqray (alpelisib). For breast cancer.
  12. Genentech’s Polivy (polatuzumab vedotin-piiq). For adults with relapsed/refractory (r/r) diffuse large B-cell lymphoma.
  13. AMAG Pharmaceuticals’ Vyleesi (bremelanotide). For hypoactive sexual desire disorder in premenopausal women.
  14. Karyopharm Therapeutics’ Xpovio (selinexor). For adults with r/r multiple myeloma (RRMM).
  15. Merck’s Recarbrio (imipenem, cilastatin and relebactam). To treat complicated urinary tract and complicated intra-abdominal infections.
  16. Shield Therapeutics’ Accrufer (ferric maltol). For iron deficiency anemia in adults.
  17. Bayer’s Nubeqa (darolutamide). For adults with nonmetastatic castration resistant prostate cancer.
  18. Daiichi Sankyo’s Turalio (pexidartinib). For adults with symptomatic tenosynovial giant cell tumor.
  19. TB Alliance’s Pretomanid. An antibiotic to treat resistant forms of tuberculosis that affects the lungs.
  20. Harmony Biosciences’ Wakix (pitolisant). For excessive daytime sleepiness (EDS) in adults with narcolepsy.
  21. Genentech’s Rozlytrek (entrectinib). For adults with metastatic non-small cell lung cancer (NSCLC) whose tumors are ROS1-positive and for adult and pediatric patients 12 years of age and older with solid tumors.
  22. Celgene Corporation’s Inrebic (fedratinib). For adults with intermediate-2 or high-risk primary or secondary myelofibrosis.
  23. AbbVie’s Rinvoq (upadacitinib). For adults with moderately to severely active rheumatoid arthritis.
  24. Nabriva Therapeutics’ Xenleta (lefamulin). To treat adults with community-acquired bacterial pneumonia.
  25. University of Iowa Health Care’s Ga-68-DOTATOC. For use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs).
  26. Kyowa Kirin’s Nourianz (istradefylline). To treat adults with Parkinson’s disease experiencing OFF episodes.
  27. Ardelyx’s Ibsrela (tenapanor). For irritable bowel syndrome with constipation in adults.
  28. Galderma’s Aklief (trifarotene). For acne vulgaris in patients 9 years of age and older.
  29. Novartis’ Beovu (brolucizumab-dbll). To treat wet age-related macular degeneration.
  30. Clinuvel’s Scenesse (afamelanotide). To increase pain-free light exposure in adults with a history of phototoxic reactions from erythropoietic protoporphyria.
  31. The Feinstein Institutes for Medical Research’s Fluorodopa F 18. A diagnostic agent for use in PET to help diagnose adults with suspected Parkinsonian syndromes (PS).
  32. Eli Lilly’s Reyvow (lasmiditan). To treat acute migraine with or without aura, in adults.
  33. Vertex Pharmaceuticals’ Trikafta (elexacafator/ivacaftor/tezacaftor). To treat patients 12 years of age and older with the most common gene mutation that causes cystic fibrosis (CF).
  34. IQ Medical Ventures’ ExEm Foam (air polymer-type A). A diagnostic agent used to assess fallopian tube openness in women with known or suspected infertility.
  35. Celgene Corporation’s Reblozyl (luspatercept-aamt). To treat anemia in adults with beta thalassemia who require regular red blood cell transfusions.
  36. BeiGene’s Brukinsa (zanubrutiib). For patients with mantle cell lymphoma.
  37. Shionogi & Co.’s Fetroja (cefiderocol). For patients with complicated urinary tract infections who have limited or no alternative treatment options.
  38. Novartis’ Adakveo (crizanlizumab-tmca). For patients with painful complication of sickle cell disease.
  39. Alnylam Pharmaceuticals’ Givlaari (givosiran). For acute hepatic porphyria.
  40. SK Biopharma’s Xcopri (cenobamate). For partial onset seizures.
  41. Global Blood Therapeutics’ Oxbryta (voxelotor). For sickle cell disease.
  42. Sarepta Therapeutics’ Vyondys 53 (golodirsen). For certain patients with Duchenne muscular dystrophy (DMD).
  43. Seattle Genetics’ Padcev (enfortumab vedotin-ejfv). For refractory bladder cancer.
  44. Dutch Ophthalmic Research Center (DORC)’s TissueBlue (Brilliant Blue G Ophthalmic Solution). Dye used in eye surgery.
  45. Intra-Cellular Therapies’ Caplyta (lumateperone tosylate). To treat schizophrenia.
  46. Eisai Co.’s Dayvigo (lemborexant). To treat insomnia.
  47. AstraZeneca and Daiichi Sankyo’s Enhertu (fam-trastuzumab deruxtecan-nxki). To treat metastatic breast cancer.
  48. Allergan’s Ubrelvy (ubrogepant). For acute treatment of migraine with or without aura in adults.