2019 FDA Drug Approvals

Certain therapeutics are classified by the US Food and Drug Administration (FDA) as “new molecular entities” or “NMEs”. These drugs typically contain active moieties that have not previously been approved by the FDA. This list outlines the new molecular entities (NMEs) and new therapeutic biological products approved by the FDA’s Center for Drug Evaluation and Research (CDER) during 2019.

January 

JEUVEAU^TM

Active Ingredient: prabotulinumtoxinA-xvfs

Approved for the temporary improvement in the appearance of moderate to severe glabellar lines related with corrugator and/or procerus muscle activity in adult patients.

Company Name: Evolus, Inc.

February

CABLIVI^®

Active Ingredient: caplacizumab-yhdp

Approved for the treatment of adult patients with acquired thrombotic thrombocytopenic purpura (aTTP).

Company Name: Ablynx NV

EGATEN^TM

Active Ingredient: triclabendazole

Approved in patients 6 years of age and older for the treatment of fascioliasis, a parasitic infestation that primarily affects the liver.

Company Name: Novartis Pharmaceuticals Corporation

March

ZULRESSO^TM

Active Ingredient: brexanolone

Approved for the treatment of postpartum depression (PPD) in adult women.

Company Name: Sage Therapeutics, Inc.

SUNOSI^®

Active Ingredient: solriamfetol

Approved to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy or obstructive sleep apnea (OSA).

Company Name: Jazz Pharmaceuticals, Inc.

MAYZENT^®

Active Ingredient: siponimod

Approved for patients diagnosed with relapsing forms of multiple sclerosis.

Company Name: Novartis Pharmaceuticals Corporation

April

EVENITY^TM

Active Ingredient: romosozumab-aqqg

Approved for the treatment of osteoporosis in postmenopausal women at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapies.

Company Name: Amgen, Inc.

BALVERSA^TM

Active Ingredient: erdafitinib

Approved for the treatment of adults with locally advanced or metastatic urothelial carcinoma that has; susceptible FGFR3 or FGFR2 genetic alterations and progressed during or following at least one line of prior platinum-containing chemotherapy, including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.

Company Name: Janssen-Cilag SpA.

SKYRIZI^TM

Active Ingredient: risankizumab-rzaa

Approved for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

Company Name: AbbVie Inc.

May

VYNDAQEL^®

Active Ingredient: tafamidis meglumine

Approved for the treatment of heart disease caused by transthyretin-mediated amyloidosis (ATTR-CM) in adult patients.

Company Name: Pfizer, Inc.

PIQRAY^®

Active Ingredient: alpelisib

Approved for the treatment of postmenopausal women, and men, with hormone receptor-positive, human epidermal growth factor receptor-2 negative (HR+/HER2-), PIK3CA-mutated, advanced or metastatic breast cancer.

Company Name: Novartis Pharmaceuticals Corporation

June

POLIVY^TM

Active Ingredient: polatuzumab vedotin-piiq

Approved in combination with bendamustine plus Rituxan® (rituximab) (BR) for the treatment of adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), who have received at least two prior therapies.

Company Name: Genentech, Inc.

VYLEESI^TM

Active Ingredient: bremelanotide

Approved for the treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women.

Company Name: AMAG Pharmaceuticals, Inc.

July

XPOVIO^TM

Active Ingredient: selinexor

Approved for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti‐CD38 monoclonal antibody.

Company Name: Karyopharm Therapeutics Inc.

RECARBRIO^TM

Active Ingredients: imipenem, cilastatin, relebactam

Approved for the treatment of adults with complicated urinary tract infections and complicated intra-abdominal infections.

Company Name: Merck Sharp & Dohme Corp.

ACCRUFER^TM

Active Ingredient: ferric maltol

Approved for use in adult patients for the treatment of iron deficiency.

Company Name: Shield Therapeutics

NUBEQA^®

Active Ingredient: darolutamide

Approved for the treatment of patients with non-metastatic castration-resistant prostate cancer.

Company Name: Bayer HealthCare Pharmaceuticals Inc.

August

TURALIO^TM

Active Ingredient: pexidartinib

Approved for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) related to severe morbidity or functional limitations and not amenable to improvement with surgery.

Company Name: Daiichi Sankyo Inc.

PRETOMANID

Active Ingredient: pretomanid

Approved for the treatment of adults with pulmonary extensively drug-resistant (XDR), treatment-intolerant or non-responsive multidrug‑resistant (MDR) tuberculosis (TB).

Company Name: Mylan Laboratories Limited

WAKIX^®

Active Ingredient: pitolisant

Approved for use in adults as a treatment for narcolepsy with or without cataplexy.

Company Name: Harmony Bioscience

ROZLYTREK^TM

Active Ingredient: entrectinib

Approved for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are ROS1-positive.

Approved for adult and pediatric patients 12 years of age and older with solid tumors that:

• have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation,
• are metastatic or where surgical resection is likely to result in severe morbidity,
• have progressed following treatment or have no satisfactory alternative therapy

Company Name: Genentech, Inc.

INREBIC^®

Active Ingredient: fedratinib

Approved for the treatment of adult patients with intermediate-2 or high-risk primary or secondary myelofibrosis.

Company Name: Impact

RINVOQ^TM

Active Ingredient: upadacitinib

Approved for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate.

Company Name: Abbvie Inc

XENLETA^TM

Active Ingredient: lefamulin

Approved for the treatment of adults with community-acquired bacterial pneumonia (CABP).

Company Name: Nabriva Therapeutics US, Inc.

Ga-68-DOTATOC

Active Ingredient: Ga-68-DOTATOC

Approved as a radioactive diagnostic agent for use with positron emission tomography (PET) for localization of somatostatin receptor-positive neuroendocrine tumors (NETs) in adult and pediatric patients.

Company Name: UIHC – P E T Imaging Center

NOURIANZ^TM

Active Ingredient: istradefylline

Approved as an adjunctive treatment to levodopa/carbidopa in adult patients with Parkinson’s disease (PD) experiencing “off” episodes.

Company Name: Kyowa Kirin, Inc.

September

IBSRELA^®

Active Ingredient: tenapanor

Approved for treatment of irritable bowel syndrome with constipation (IBS-C) in adults.

Company Name: Ardelyx, Inc.

October

AKLIEF^®

Active Ingredient: trifarotene

Approved for the topical treatment of acne vulgaris in patients 9 years and older.

Company Name: Galderma Laboratories, L.P.

BEOVU^®

Active Ingredient: brolucizumab–dbll

Approved for the treatment of Neovascular (Wet) Age-related Macular Degeneration (AMD).

Company Name: Novartis Pharmaceuticals Corporation

SCENESSE^®

Active Ingredient: afamelanotide

Approved for use in adult patients with a confirmed diagnosis of erythropoietic protoporphyria (EPP) to increase their tolerance to sunlight.

Company Name: Clivunel

FLUORODOPA F 18

Active Ingredient: fluorodopa F 18

Approved as a diagnostic agent for use in positron emission tomography (PET) to help diagnose adult patients with suspected Parkinsonian syndromes (PS).

Manufactured by: The Feinstein Institutes for Medical Research

REYVOW^TM

Active Ingredient: asmiditan

Approved for the acute treatment of migraine with or without aura in adults.

Company Name: Eli Lilly and Co

TRIKAFTA^TM

Active Ingredients: elexacaftor, ivacaftor, tezacaftor

Approved for use in patients 12 years and older with at least one F508del mutation in the CFTR gene – the most common gene mutation that causes cystic fibrosis.

Company Name: Vertex Pharmaceuticals

November

EXEM^® FOAM

Active Ingredient: air polymer-type A

Approved as a diagnostic agent used to assess fallopian tube patency (openness) in women with known or suspected infertility.

Company Name: GISKIT B.V.

REBLOZYL^®

Active Ingredient: luspatercept–aamt

Approved for the treatment of adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions.

Company Name: Celgene Corporation

BRUKINSA^TM

Active Ingredient: zanubrutinib

Approved for the treatment of certain patients with mantle cell lymphoma, a form of blood cancer.

Company Name: Beigene USA

FETROJA^®

Active Ingredient: cefiderocol

Approved for use in patients 18 years or older who have limited or no alternative treatment options, for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis caused by susceptible Gram-negative microorganisms.

Company Name: Shionogi Inc.

ADAKVEO^®

Active Ingredient: crizanlizumab-tmca

Approved as a treatment to reduce the frequency of vaso-occlusive crises in adults and pediatric patients aged 16 years and older with sickle cell disease.

Company Name: Novartis Pharmaceuticals Corporation

GIVLAARI^TM

Active Ingredient: givosiran

Approved for the treatment of adults with acute hepatic porphyria.

Company Name: Alnylam Pharmaceuticals, Inc.

XCOPRI^®

Active Ingredient: cenobamate

Approved for the treatment of partial-onset seizures in adult patients.

Company Name: SK Life Science, Inc.

OXBRYTA^TM

Active Ingredient: voxelotor

Approved for the treatment of sickle cell disease in adults and pediatric patients 12 years and older.

Company Name: Global Blood Therapeutics

December

VYONDYS 53^TM

Active Ingredient: golodirsen

Approved for the treatment of Duchenne muscular dystrophy (DMD) patients who have a confirmed mutation of the DMD gene that is amenable to exon 53 skipping.

Company Name: Sarepta Therapeutics

PADCEV^TM

Active Ingredient: enfortumab vedotin-ejfv

Approved for the treatment of refractory bladder cancer.

Company Name: Astellas Pharma, Inc.

TISSUEBLUE^TM

Active Ingredient: Brilliant Blue G Ophthalmic Solution

Approved for use as a dye used in eye surgery.

Company Name: Dutch Ophthalmic Research Center B.V.

CAPLYTA^®

Active Ingredient: lumateperone tosylate

Approved for the treatment of schizophrenia.

Company Name: Intra-Cellular Therapies, Inc.

DAYVIGO^TM

Active Ingredient: lemborexant

Approved for the treatment of insomnia.

Company Name: Eisai, Inc.

ENHURTU^®

Active Ingredient: fam-trastuzumab deruxtecan-nxki

Approved for the treatment of schizophrenia.

Company Name: Daiicgi Sankyo Company, Limited

UBRELVY^TM

Active Ingredient: ubrogepant

Approved for the acute treatment of migraine with or without aura in adults.

Company Name: Allergan, plc.

Reference: U.S. Food and Drug Administration. (2019). Novel Drug Approvals for 2019. [Online] Available at: https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2019 [Accessed 19 Dec. 2019].

List last updated January 03, 2020