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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Zalviso (sufentanil) Sublingual Microtablet System

Company: AcelRx Pharmaceuticals, Inc.
Treatment for: Pain

Zalviso (sufentanil sublingual microtablet system) is a patient-activated, non-invasive analgesic system for the management of moderate-to-severe acute pain in adult patients in the hospital setting.

naloxone Nasal Spray

Treatment for: Opioid Overdose

Naloxone Nasal Spray is an opioid antagonist intranasal formulation in development for the treatment of opioid overdose.

Levosert (levonorgestrel)

Company: Medicines360 and Actavis plc
Treatment for: Contraception

Levosert (levonorgestrel) is a hormonal intrauterine contraceptive (IUC) for use by women to prevent pregnancy.

Esbriet (pirfenidone)

Company: InterMune, Inc.
Treatment for: Idiopathic Pulmonary Fibrosis

Esbriet (pirfenidone) is an orally active small molecule drug that may inhibit collagen synthesis, down regulate production of multiple cytokines and block fibroblast proliferation and stimulation in response to cytokines. Pirfenidone is in development for the treatment of patients with idiopathic pulmonary fibrosis (IPF).


Company: Boehringer Ingelheim Pharmaceuticals, Inc.
Treatment for: Idiopathic Pulmonary Fibrosis

Nintedanib is an investigational small molecule tyrosine kinase inhibitor (TKI) in development for the treatment of idiopathic pulmonary fibrosis.


Company: Astellas
Treatment for: Aspergillosis -- Invasive

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

Toujeo (insulin glargine [rDNA origin])

Company: Sanofi
Treatment for: Diabetes Type 1, Diabetes Type 2

Toujeo (insulin glargine [rDNA origin] is an investigational basal insulin in development for the treatment of diabetes.


Company: AstraZeneca
Treatment for: Ovarian Cancer

Olaparib is an investigational, potential first-in-class oral poly ADP ribose polymerase (PARP) inhibitor in development for the treatment of ovarian cancer.

lamivudine and raltegravir

Company: Merck
Treatment for: HIV Infection

Lamivudine and raltegravir is a fixed-dose combination of a nucleoside analog reverse transcriptase inhibitor and an integrase strand transfer inhibitor in development for the treatment of HIV-1 infection.


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

Empagliflozin is an investigational sodium glucose co-transporter-2 (SGLT2) inhibitor in development for the treatment of type 2 diabetes.

Lyxumia (lixisenatide)

Company: Sanofi
Treatment for: Diabetes Type 2

Lyxumia (lixisenatide) is a once-daily prandial GLP-1 receptor agonist in development for the treatment of adults with type 2 diabetes mellitus.

Movantik (naloxegol)

Company: AstraZeneca
Treatment for: Opioid-Induced Constipation

Movantik (naloxegol) is a peripherally-acting mu-opioid receptor antagonist being investigated for the treatment of constipation as a side effect of prescription opioid pain medicines.

TNX-102 (cyclobenzaprine hydrochloride)

Company: Tonix Pharmaceuticals Holding Corp.
Treatment for: Post Traumatic Stress Disorder

TNX-102 (cyclobenzaprine) is a sublingual formulation of an approved skeletal muscle relaxant in development for the treatment of patients with post-traumatic stress disorder (PTSD).

Sivextro (tedizolid phosphate) Tablets and Injection

Company: Cubist Pharmaceuticals, Inc.
Treatment for: Skin and Structure Infection

Sivextro (tedizolid phosphate) is an oxazolidinone antibiotic drug indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI).


Company: Prosensa Holding N.V.
Treatment for: Duchenne Muscular Dystrophy

Drisapersen is an investigational antisense oligonucleotide in development for the treatment of Duchenne Muscular Dystrophy.

Triferic (ferric pyrophosphate citrate)

Company: Rockwell Medical, Inc.
Treatment for: Anemia Associated with Chronic Renal Failure

Triferic (ferric pyrophosphate citrate) is an investigational iron-replacement drug for treating iron deficiency in chronic kidney disease patients receiving hemodialysis.

Zerenex (ferric citrate coordination complex)

Company: Keryx Biopharmaceuticals, Inc.
Treatment for: Hyperphosphatemia of Renal Failure

Zerenex (ferric citrate coordination complex) is a ferric iron-based phosphate binder in development for the treatment of hyperphosphatemia in patients with chronic kidney disease.

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

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