FDA Approved Drugs in Year 2019: List of Latest New Drug Therapy Approve

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

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