FDA Approved Drugs in Year 2019: List of Latest New Drug Therapy Approve
admin GPAT Preparation, Pharma Alerts, Pharma News, Study Material alpelisib for breast cancer, bremelanotide uses premenopausal women., brexanolone for postpartum depression, caplacizumab approval, darolutamide uses for non-metastatic castration resistant prostate cancer, Drugs approved by USFDA 2019, erdafitinib approval date, List of Approved drug in 2019, pexidartinib, pitolisant uses To treat excessive daytime sleepiness, polatuzumab vedotin for B Cell Lymphoma, prabotulinumtoxinA-xvfs, risankizumab, romosozumab, selinexor uses refractory multiple myeloma, siponimod for multiple sclerosis, solriamfetol uses for narcolepsy or obstructive sleep apnea, tafamidis meglumine, triclabendazole us fda, ubrogepant for migraine treatment, US FDA approval in 2019
In year 2019 US FDA approved total 48 drugs.
Find out the list of new drug therapy approved by FDA. This list contain name of active ingredient, brand name of the drug, date of its approval and its therapeutic uses.
| No. | Brand Name of Drug | Drug Name (Active Ingredient) | Approval Date | FDA-approved use on approval date* |
| 1 | Ubrelvy | ubrogepant | 12/23/2019 | to treat acute treatment of migraine with or without aura in adults |
| 2 | Enhertu | fam-trastuzumab deruxtecan-nxki | 12/20/2019 | To treat metastatic breast cancer |
| 3 | Dayvigo | lemborexant | 12/20/2019 | To treat insomnia |
| 4 | Caplyta | lumateperone tosylate | 12/20/2019 | To treat schizophrenia |
| 5 | TissueBlue | Brilliant Blue G Ophthalmic Solution | 12/20/2019 | Dye used in eye surgery |
| 6 | Padcev | enfortumab vedotin-ejfv | 12/18/2019 | To treat refractory bladder cancer |
| 7 | Vyondys 53 | golodirsen | 12/12/2019 | To treat certain patients with Duchenne muscular dystrophy |
| 8 | Oxbryta | voxelotor | 11/25/2019 | To treat sickle cell disease |
| 9 | Xcopri | cenobamate | 11/21/2019 | To treat partial onset seizures |
| 10 | Givlaari | givosiran | 11/20/2019 | To treat acute hepatic porphyria, a rare blood disorder |
| 11 | Adakveo | crizanlizumab-tmca | 11/15/2019 | To treat patients with painful complication of sickle cell disease |
| 12 | Fetroja | cefiderocol | 11/14/2019 | To treat patients with complicated urinary tract infections who have limited or no alternative treatment options |
| 13 | Brukinsa | zanubrutinib | 11/14/2019 | To treat certain patients with mantle cell lymphoma, a form of blood cancer |
| 14 | Reblozyl | luspatercept–aamt | 11/8/2019 | For the treatment of anemia in adult patients with beta thalassemia who require regular red blood cell transfusions |
| 15 | ExEm Foam | air polymer-type A | 11/7/2019 | A diagnostic agent used to assess fallopian tube patency (openness) in women with known or suspected infertility |
| 16 | Trikafta | 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 |
| 17 | Reyvow | lasmiditan | 10/11/2019 | For the acute treatment of migraine with or without aura, in adults |
| 18 | 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) | |
| 19 | Scenesse | 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 |
| 20 | Beovu | brolucizumab–dbll | 10/7/2019 | Treatment of wet age-related macular degeneration |
| 21 | Aklief | trifarotene | 10/4/2019 | For the topical treatment of acne vulgaris in patients 9 years of age and older |
| 22 | Ibsrela | tenapanor | 9/12/2019 | To treat irritable bowel syndrome with constipation in adults. |
| 23 | Nourianz | istradefylline | 8/27/2019 | To treat adult patients with Parkinson’s disease experiencing “off” episodes |
| 24 | Ga-68-DOTATOC | Ga-68-DOTATOC | 8/21/2019 | For use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) |
| 25 | Xenleta | lefamulin | 8/19/2019 | To treat adults with community-acquired bacterial pneumonia |
| 26 | Rinvoq | upadacitinib | 8/16/2019 | To treat adults with moderately to severely active rheumatoid arthritis |
| 27 | Inrebic | fedratinib | 8/16/2019 | To treat adult patients with intermediate-2 or high-risk primary or secondary myelofibrosis |
| 28 | Rozlytrek | 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 | ||||
| 29 | Wakix | pitolisant | 8/14/2019 | To treat excessive daytime sleepiness (EDS) in adult patients with narcolepsy |
| 30 | pretomanid | 8/14/2019 | For treatment-resistant forms of tuberculosis that affects the lungs | |
| 31 | Turalio | pexidartinib | 8/2/2019 | To treat adult patients with symptomatic tenosynovial giant cell tumor |
| 32 | Nubeqa | darolutamide | 7/30/2019 | To treat adult patients with non-metastatic castration resistant prostate cancer |
| 33 | Accrufer | ferric maltol | 7/25/2019 | To treat iron deficiency anemia in adults |
| 34 | Recarbrio | imipenem, cilastatin and relebactam | 7/16/2019 | To treat complicated urinary tract and complicated intra-abdominal infections |
| 35 | Xpovio | selinexor | 7/3/2019 | To treat adult patients with relapsed or refractory multiple myeloma (RRMM) |
| 36 | Vyleesi | bremelanotide | 6/21/2018 | To treat hypoactive sexual desire disorder in premenopausal women. |
| 37 | Polivy | polatuzumab vedotin-piiq | 6/10/2019 | To treat adult patients with relapsed or refractory diffuse large B-cell lymphoma |
| 38 | Piqray | alpelisib | 5/24/2019 | To treat breast cancer |
| 39 | Vyndaqel | tafamidis meglumine | 5/3/2019 | To treat heart disease (cardiomyopathy) caused by transthyretin mediated amyloidosis (ATTR-CM) in adults |
| 40 | Skyrizi | risankizumab-rzaa | 4/23/2019 | To treat moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy |
| 41 | Balversa | erdafitinib | 4/12/2019 | To treat adult patients with locally advanced or metastatic bladder cancer |
| 42 | Evenity | romosozumab-aqqg | 4/9/2019 | To treat osteoporosis in postmenopausal women at high risk of fracture |
| 43 | Mayzent | siponimod | 3/26/2019 | To treat adults with relapsing forms of multiple sclerosis |
| 44 | Sunosi | solriamfetol | 3/20/2019 | To treat excessive sleepiness in adult patients with narcolepsy or obstructive sleep apnea |
| 45 | brexanolone | 3/19/2019 | To treat postpartum depression (PPD) in adult women | |
| 46 | Egaten | 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” |
| 47 | Cablivi | caplacizumab-yhdp | 2/6/2019 | To treat adult patients with acquired thrombotic thrombocytopenic purpura (aTTP) |
| 48 | Jeuveau | 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 |