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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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Yosprala (aspirin and omeprazole)

Company: Pozen Inc.
Treatment for: Ischemic Stroke -- Prophylaxis, Gastric Ulcer Prophylaxis

Yosprala (aspirin and omeprazole) is a platelet aggregation inhibitor and proton pump inhibitor combination in development for the secondary prevention of cardiovascular disease in patients at risk for aspirin-associated gastric ulcers.

Ibrance (palbociclib)

Company: Pfizer Inc.
Treatment for: Breast Cancer

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

Xtampza ER (oxycodone) Extended-Release Capsules

Company: Collegium Pharmaceutical, Inc.
Treatment for: Chronic Pain

Xtampza ER (oxycodone) is an extended-release, abuse-deterrent narcotic analgesic in development for the treatment of chronic pain.

patiromer for Oral Suspension

Company: Relypsa, Inc.
Treatment for: Hyperkalemia

Patiromer is an oral potassium binder in development for the treatment of hyperkalemia.

cobimetinib

Company: Genentech
Treatment for: Melanoma - Metastatic

Cobimetinib is an investigational MEK inhibitor in development for the combination treatment of advanced melanoma.

defibrotide

Company: Jazz Pharmaceuticals plc
Treatment for: Hepatic Veno-Occlusive Disease

Defibrotide is a deoxyribonucleic acid derivative anticoagulant in development for the treatment of severe hepatic veno-occlusive disease (VOD).

avibactam and ceftazidime

Company: Actavis plc
Treatment for: Intraabdominal Infection

Avibactam and ceftazidime is a next generation, non-β lactam β-lactamase inhibitor and third-generation, antipseudomonal cephalosporin investigational antibiotic combination in development for the treatment of complicated intra-abdominal infections.

Yondelis (trabectedin)

Company: Ortho Biotech Products, L.P.
Treatment for: Ovarian Cancer

Yondelis (trabectedin) is an investigational cytotoxic antitumor agent in development for the treatment of relapsed ovarian cancer, and advanced soft tissue sarcoma.

brincidofovir

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.

evolocumab

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.

secukinumab

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.

mepolizumab

Company: GlaxoSmithKline plc
Treatment for: Asthma

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

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

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