Clinical Pharmacy

FDA-Approved Drugs in 2019!

Nov 5th, 2020
fda approved drugs 2019

2019 FDA-Approved Medicines

42 novel drugs were FDA-approved in 2019 compared to 59 drugs the year before.

Below, we have put together these new FDA-approvals – though the table does not include allergenic or blood or vaccine-related products. Similarly, plasma derivatives or gene therapy products are not included.

See below for a full list of FDA approvals and, for more information, visit the FDA website.

List of 2019 FDA-Approved Drugs

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Drug  Active Ingredient Date Approved Indication
Ubrelvyubrogepant 12/23/2019Acute treatment of migraine with or without aura in adults
Enhertufam-trastuzumab deruxtecan-nxki 12/20/2019Metastatic breast cancer
lemborexant 12/20/2019Insomnia
lumateperonetosylate 12/20/2019Schizophrenia
TissueBlueBrilliant Blue G Ophthalmic Solution 12/20/2019Dye used in eye surgery
Padcevenfortumabvedotin-ejfv 12/18/2019Refractory bladder cancer
Vyondys 53golodirsen 12/12/2019Duchenne muscular dystrophy
Oxbrytavoxelotor 11/25/2019Sickle cell disease
Xcopricenobamate 11/21/2019Partial onset seizures
Givlaarigivosiran 11/20/2019Acute hepatic porphyria
Adakveocrizanlizumab-tmca 11/15/2019Patients with painful complication of sickle cell disease
Fetrojacefiderocol 11/14/2019To treat patients with complicated urinary tract infections who have limited or no alternative treatment options
Brukinsazanubrutinib 11/14/2019To treat certain patients with mantle cell lymphoma, a form of blood cancer
Reblozylluspatercept–aamt 11/8/2019Anemia in adult patients with beta thalassemia who require regular erythrocyte transfusions
ExEm Foamair polymer-type A 11/7/2019A diagnostic agent used to assess fallopian tube patency (openness) in women with known or suspected infertility
10/21/2019To treat patients 12 years of age and older with the most common gene mutation that causes cystic fibrosis
Reyvowlasmiditan 10/11/2019Migraine with or without aura, in adults
 fluorodopa F 18 10/10/2019A diagnostic agent for use in positron emission tomography (PET) to help diagnose adult patients with suspected Parkinsonian syndromes (PS)
Scenesseafamelanotide 10/8/2019To increase pain-free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporphyria
Beovubrolucizumab–dbll 10/7/2019Treatment of wet age-related macular degeneration
Aklieftrifarotene10/4/2019Acne vulgaris in patients 9 years of age and older (topical use)
Ibsrelatenapanor9/12/2019Irritable bowel syndrome with constipation in adults.
Nourianzistradefylline 8/27/2019Parkinson’s disease in those experiencing “off” episodes
Ga-68-DOTATOCGa-68-DOTATOC 8/21/2019For use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs)
Xenletalefamulin 8/19/2019Community-acquired bacterial pneumonia
Rinvoqupadacitinib 8/16/2019Rheumatoid arthritis
Inrebicfedratinib 8/16/2019To treat adult patients with intermediate-2 or high-risk primary or secondary myelofibrosis
Rozlytrekentrectinib 8/15/2019Metastatic non-small cell lung cancer (NSCLC) whose tumors are ROS1-positive
Wakixpitolisant 8/14/2019Excessive daytime sleepiness (EDS) in adult patients with narcolepsy
 pretomanid 8/14/2019For treatment-resistant forms of tuberculosis
Turaliopexidartinib8/2/2019Symptomatictenosynovial giant cell tumor
Nubeqadarolutamide 7/30/2019Non-metastatic castration resistant prostate cancer
Accruferferric maltol 7/25/2019Iron deficiency anemia in adults
7/16/2019Complicated urinary tract and complicated intra-abdominal infections
Xpovioselinexor7/3/2019Adult patients with relapsed or refractory multiple myeloma (RRMM)
Vyleesibremelanotide 6/21/2018Hypoactive sexual desire disorder in premenopausal women.
Polivypolatuzumabvedotin-piiq 6/10/2019Adult patients with relapsed or refractory diffuse large B-cell lymphoma
Piqrayalpelisib 5/24/2019Breast cancer
Vyndaqeltafamidis meglumine5/3/2019Cardiomyopathy) caused by transthyretin mediated amyloidosis (ATTR-CM) in adults
Skyrizirisankizumab-rzaa 4/23/2019Plaque psoriasis in adults who are candidates for systemic therapy or phototherapy
Balversaerdafitinib 4/12/2019Advanced or metastatic bladder cancer
Evenityromosozumab-aqqg4/9/2019Osteoporosis in postmenopausal women at high risk of fracture
Mayzentsiponimod 3/26/2019Relapsing forms of multiple sclerosis
Sunosisolriamfetol 3/20/2019To treat excessive sleepiness in adult patients with narcolepsy or obstructive sleep apnea
Zulressobrexanolone 3/19/2019Postpartum depression (PPD) in adult women
Egatentriclabendazole 2/13/2019Fascioliasis
Cablivicaplacizumab-yhdp2/6/2019Acquired thrombotic thrombocytopenic purpura (aTTP)
JeuveauprabotulinumtoxinA-xvfs2/1/2019For the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients