Introduction

Below, you can find all FDA-approved drugs in 2019.

Bear in mind that this list covers only new molecular entities (NME’s) and biologic products. The list does not include plasma derivatives, vaccines, or other products involved in blood, gene therapy, or allergenics.

You may not have heard of many of these drugs, but they will become more and more apparent in the coming years.

Shortly, we will be adding more content on all 2019 FDA Approved drugs to our registered members learning portal.

Below, though, you can begin to learn more about these novel drugs and medicines.

List of 2019 FDA-Approved Drugs

Drug  Active Ingredient Date Approved Indication
Ubrelvy ubrogepant 12/23/2019 Acute treatment of migraine with or without aura in adults
Enhertu fam-trastuzumab deruxtecan-nxki 12/20/2019 Metastatic breast cancer
Dayvigo
 
lemborexant 12/20/2019 Insomnia
Caplyta
 
lumateperonetosylate 12/20/2019 Schizophrenia
TissueBlue Brilliant Blue G Ophthalmic Solution 12/20/2019 Dye used in eye surgery
Padcev enfortumabvedotin-ejfv 12/18/2019 Refractory bladder cancer
Vyondys 53 golodirsen 12/12/2019 Duchenne muscular dystrophy
Oxbryta voxelotor 11/25/2019 Sickle cell disease
Xcopri cenobamate 11/21/2019 Partial onset seizures
Givlaari givosiran 11/20/2019 Acute hepatic porphyria
Adakveo crizanlizumab-tmca 11/15/2019 Patients with painful complication of sickle cell disease
Fetroja cefiderocol 11/14/2019 To treat patients with complicated urinary tract infections who have limited or no alternative treatment options
Brukinsa zanubrutinib 11/14/2019 To treat certain patients with mantle cell lymphoma, a form of blood cancer
Reblozyl luspatercept–aamt 11/8/2019 Anemia in adult patients with beta thalassemia who require regular erythrocyte transfusions
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
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
Reyvow lasmiditan 10/11/2019 Migraine with or without aura, in adults
  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)
Scenesse afamelanotide 10/8/2019 To increase pain-free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporphyria
Beovu brolucizumab–dbll 10/7/2019 Treatment of wet age-related macular degeneration
Aklief trifarotene 10/4/2019 Acne vulgaris in patients 9 years of age and older (topical use)
Ibsrela tenapanor 9/12/2019 Irritable bowel syndrome with constipation in adults.
Nourianz istradefylline 8/27/2019 Parkinson’s disease in those experiencing “off” episodes
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)
Xenleta lefamulin 8/19/2019 Community-acquired bacterial pneumonia
Rinvoq upadacitinib 8/16/2019 Rheumatoid arthritis
Inrebic fedratinib 8/16/2019 To treat adult patients with intermediate-2 or high-risk primary or secondary myelofibrosis
Rozlytrek entrectinib 8/15/2019 Metastatic non-small cell lung cancer (NSCLC) whose tumors are ROS1-positive
Wakix pitolisant 8/14/2019 Excessive daytime sleepiness (EDS) in adult patients with narcolepsy
  pretomanid 8/14/2019 For treatment-resistant forms of tuberculosis
Turalio pexidartinib 8/2/2019 Symptomatictenosynovial giant cell tumor
Nubeqa darolutamide 7/30/2019 Non-metastatic castration resistant prostate cancer
Accrufer ferric maltol 7/25/2019 Iron deficiency anemia in adults
Recarbrio imipenem, cilastatin and relebactam 7/16/2019 Complicated urinary tract and complicated intra-abdominal infections
Xpovio selinexor 7/3/2019 Adult patients with relapsed or refractory multiple myeloma (RRMM)
Vyleesi bremelanotide 6/21/2018 Hypoactive sexual desire disorder in premenopausal women.
Polivy polatuzumabvedotin-piiq 6/10/2019 Adult patients with relapsed or refractory diffuse large B-cell lymphoma
Piqray alpelisib 5/24/2019 Breast cancer
Vyndaqel tafamidis meglumine 5/3/2019 Cardiomyopathy) caused by transthyretin mediated amyloidosis (ATTR-CM) in adults
Skyrizi risankizumab-rzaa 4/23/2019 Plaque psoriasis in adults who are candidates for systemic therapy or phototherapy
Balversa erdafitinib 4/12/2019 Advanced or metastatic bladder cancer
Evenity romosozumab-aqqg 4/9/2019 Osteoporosis in postmenopausal women at high risk of fracture
Mayzent siponimod 3/26/2019 Relapsing forms of multiple sclerosis
Sunosi solriamfetol 3/20/2019 To treat excessive sleepiness in adult patients with narcolepsy or obstructive sleep apnea
Zulresso brexanolone 3/19/2019 Postpartum depression (PPD) in adult women
Egaten triclabendazole 2/13/2019 Fascioliasis
Cablivi caplacizumab-yhdp 2/6/2019 Acquired thrombotic thrombocytopenic purpura (aTTP)
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