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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.

obeticholic acid

Company: Intercept Pharmaceuticals, Inc.
Treatment for: Biliary Cirrhosis

Obeticholic acid is a first-in-class farnesoid X receptor (FXR) agonist in development for the treatment of primary biliary cirrhosis.

MM-398 (irinotecan liposomal) Injection

Company: Merrimack Pharmaceuticals, Inc.
Treatment for: Pancreatic Cancer

MM-398 (irinotecan liposome injection) is a liposomal formulation of the topoisomerase I inhibitor irinotecan in development for the treatment of post-gemcitabine metastatic adenocarcinoma of the pancreas.

BromSite (bromfenac) Ophthalmic Solution

Company: InSite Vision Incorporated
Treatment for: Postoperative Ocular Inflammation

BromSite (bromfenac) is a low dose nonsteroidal anti-inflammatory drug (NSAID) ophthalmic solution in development for the treatment of inflammation and prevention of pain in cataract surgery.


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: Santhera Pharmaceuticals
Treatment for: Duchenne Muscular Dystrophy

Idebenone is a synthetic short-chain benzoquinone and a substrate for the enzyme NAD(P)H:quinone oxidoreductase (NQO1) in development for the treatment of Duchenne Muscular Dystrophy.

Praluent (alirocumab)

Company: Sanofi and Regeneron Pharmaceuticals, Inc.
Treatment for: High Cholesterol

Praluent (alirocumab) an investigational monoclonal antibody targeting PCSK9 (proprotein convertase subtilisin/kexin type 9) in development for the treatment of patients with high cholesterol.

Androxal (enclomiphene)

Company: Repros Therapeutics Inc.
Treatment for: Hypogonadism -- Male

Androxal (enclomiphene) is a non-steroidal estrogen receptor antagonist in development for secondary hypogonadism in overweight men wishing to restore normal testicular function.


Company: Janssen Research & Development, LLC
Treatment for: Multiple Myeloma

Daratumumab is an investigational human anti-CD38 monoclonal antibody in development for the treatment of patients with multiple myeloma.

Locilex (pexiganan) Cream

Company: Dipexium Pharmaceuticals, Inc.
Treatment for: Diabetic Foot Infection

Locilex (pexiganan cream 0.8%) is a topical antibiotic in development for the treatment of patients with diabetic foot infection.

Rayaldee (calcifediol)

Company: OPKO Health, Inc.
Treatment for: Secondary Hyperparathyroidism

Rayaldee (calcifediol) is a first-in-class oral vitamin D prohormone treatment in development for secondary hyperparathyroidism in patients with stage 3 or 4 chronic kidney disease and vitamin D insufficiency.

Anthim (obiltoxaximab)

Company: Elusys Therapeutics, Inc.
Treatment for: Anthrax Prophylaxis, Inhalation Bacillus anthracis

Anthim (obiltoxaximab) is a high-affinity monoclonal antibody in development for the treatment and prevention of inhalational anthrax.

elbasvir and grazoprevir

Company: Merck & Co., Inc.
Treatment for: Chronic Hepatitis C

Elbasvir and grazoprevir is an investigational, once-daily single tablet NS5A replication complex inhibitor and NS3/4A protease inhibitor combination in development for the treatment of multiple HCV genotypes.

ZS-9 (sodium zirconium cyclosilicate)

Company: ZS Pharma, Inc.
Treatment for: Hyperkalemia

ZS-9 (sodium zirconium cyclosilicate) is a crystalline lattice potassium ion-trap in development for the treatment of hyperkalemia.

Dyanavel XR (amphetamine)

Company: Tris Pharma, Inc.
Treatment for: ADHD

Dyanavel XR (amphetamine) is an extended-release oral suspension formulation of amphetamine in development for the treatment of children with ADHD.

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

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