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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.


Company: Clovis Oncology, Inc.
Treatment for: Non-Small Cell Lung Cancer

Rociletinib is a mutant-selective inhibitor of epidermal growth factor receptor (EGFR) in development for the treatment of EGFR-mutated non-small cell lung cancer (NSCLC).

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.

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.

Rayaldee (calcifediol)

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

Rayaldee (calcifediol modified-release) 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.


Company: Takeda Pharmaceutical Company Limited
Treatment for: Multiple Myeloma

Ixazomib is an investigational oral proteasome inhibitor in development for the treatment of patients with relapsed and/or refractory multiple myeloma.


Company: Ignyta, Inc.
Treatment for: Neuroblastoma

Entrectinib is a potent, novel, orally available, selective tyrosine kinase inhibitor in development for the treatment of neuroblastoma.

emtricitabine, rilpivirine and tenofovir alafenamide

Company: Gilead Sciences, Inc.
Treatment for: HIV Infection

Emtricitabine/rilpivirine/tenofovir alafenamide is an investigational nucleoside analog HIV-1 reverse transcriptase inhibitor (NRTI), non-nucleoside reverse transcriptase inhibitor (NNRTI) and nucleotide reverse transcriptase inhibitor (NtRTI) fixed-dose combination in development for the treatment of HIV-1 infection.


Company: Genentech
Treatment for: Melanoma - Metastatic

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

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) Injection

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

Praluent (alirocumab) is a PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitor monoclonal antibody for the treatment of heterozygous familial hypercholesterolemia, or patients with atherosclerotic heart disease who require additional lowering of LDL-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.

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

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