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New Drug Applications

The New Drug Application (NDA) is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the United States.
The purpose of a NDA is to provide enough information to permit the FDA to reach the following key decisions

  • Whether the drug is safe and effective in its proposed use(s), and whether the benefits of the drug outweigh the risks
  • Whether the drug's proposed labeling (package insert) is appropriate and what it should contain
  • Whether the methods used in manufacturing the drug and the controls used to maintain the drug's quality are adequate to preserve the drug's identity, strength, quality, and purity

For more information on New Drug Applications, please visit the FDA's How Drugs are Developed and Approved page.

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Opdivo (nivolumab)

Company: Bristol-Myers Squibb Company
Treatment for: Melanoma - Metastatic

Opdivo (nivolumab) is an investigational PD-1 immune checkpoint inhibitor in development for the treatment of advanced melanoma.


Company: Chimerix, Inc.
Treatment for: Ebola Virus Disease

Brincidofovir is a nucleotide analog broad-spectrum antiviral under FDA review to assess the safety and efficacy in patients with confirmed Ebola virus infection.


Company: Amgen Inc.
Treatment for: Hyperlipidemia

Evolocumab is a monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9) in development for the treatment for dyslipidemia.


Company: Novartis Pharmaceuticals Corporation
Treatment for: Plaque Psoriasis

Secukinumab is a selective interleukin-17A (IL-17A) inhibitor in development for the treatment of moderate-to-severe plaque psoriasis.

Macrilen (macimorelin acetate)

Company: Aeterna Zentaris Inc.
Treatment for: Adult Human Growth Hormone Deficiency

Macrilen (macimorelin) is a ghrelin agonist in development for use in evaluating adult growth hormone deficiency (AGHD).

LBH589 (panobinostat)

Company: Novartis
Treatment for: Multiple Myeloma

LBH589 (panobinostat) is a pan-deacetylase (pan-DAC) inhibitor in development for the combination treatment of multiple myeloma.

ivacaftor and lumacaftor

Company: Vertex Pharmaceuticals Incorporated
Treatment for: Cystic Fibrosis

Ivacaftor and lumacaftor is a CFTR potentiator and CFTR corrector combination designed to treat the underlying cause of cystic fibrosis in people with two copies of the F508del mutation.


Company: GlaxoSmithKline plc
Treatment for: Asthma

Mepolizumab is an anti-IL5 monoclonal antibody in development for the treatment of patients with severe eosinophilic asthma.


Company: Astellas
Treatment for: Aspergillosis -- Invasive

Isavuconazole is a broad-spectrum antifungal in development for the treatment of invasive aspergillosis and invasive mucormycosis.

Savaysa (edoxaban)

Company: Daiichi Sankyo Company
Treatment for: Prevention of Thromboembolism in Atrial Fibrillation, Deep Vein Thrombosis, Pulmonary Embolism, Venous Thromboembolism

Savaysa (edoxaban) is an investigational, oral, once-daily factor Xa inhibitor anticoagulant in development for the reduction in risk of stroke in patients with non-valvular atrial fibrillation (NVAF), and deep vein thrombosis (DVT) or pulmonary embolism.

Remoxy (oxycodone)

Company: Pain Therapeutics, Inc. and King Pharmaceuticals, Inc.
Treatment for: Pain

Remoxy (oxycodone) is a long-acting abuse-resistant narcotic analgesic formulation in development for the treatment of moderate to severe chronic pain.

patiromer for Oral Suspension

Company: Relypsa, Inc.
Treatment for: Hyperkalemia

Patiromer is an oral potassium binder being developed for the treatment of hyperkalemia.

empagliflozin and metformin

Company: Eli Lilly and Company and Boehringer Ingelheim
Treatment for: Diabetes Type 2

Empagliflozin and Metformin is a sodium glucose co-transporter-2 (SGLT2) inhibitor and biguanide combination in development for the treatment of type 2 diabetes.


Company: Eisai Co., Ltd.
Treatment for: Thyroid Cancer

Lenvatinib is an oral multiple receptor tyrosine kinase (RTK) inhibitor in development for the treatment of progressive radioiodine-refractory differentiated thyroid cancer.


Company: Pfizer Inc.
Treatment for: Breast Cancer

Palbociclib is a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor in development for the combination treatment of ER+, HER2- metastatic breast cancer.

See also: Generic Approvals, New Drug Approvals, Recent Additions to, Alphabetical Listing of all New Drug Applications, FDA Approval Process

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