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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Cresemba (isavuconazonium)

Company: Astellas

Cresemba (isavuconazonium) is a novel, water-soluble prodrug of the triazole isavuconazole, in development for the treatment of invasive aspergillosis and mucormycosis.

brivaracetam

Company: UCB, Inc.
Treatment for: Epilepsy

Brivaracetam is an analogue of levetiracetam in development for the treatment of partial-onset seizures in patients with epilepsy.

deflazacort

Company: Marathon Pharmaceuticals, LLC
Treatment for: Duchenne Muscular Dystrophy

Deflazacort is a glucocorticoid in development for the treatment of Duchenne Muscular Dystrophy.

Zarxio (filgrastim)

Company: Sandoz
Treatment for: Neutropenia Associated with Chemotherapy

Zarxio (filgrastim) is an investigational biosimilar (reference product Amgen’s Neupogen®) under review for the treatment of neutropenia associated with chemotherapy.

patiromer for Oral Suspension

Company: Relypsa, Inc.
Treatment for: Hyperkalemia

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

asfotase alfa

Company: Alexion Pharmaceuticals, Inc.
Treatment for: Hypophosphatasia

Asfotase alfa is an investigational, first-in-class enzyme replacement therapy for the treatment of hypophosphatasia.

safinamide

Company: Newron Pharmaceuticals S.p.A.
Treatment for: Parkinson's Disease

Safinamide is an alpha-aminoamide in development as an add-on therapy to dopamine agonists or to levodopa in patients with early or mid- to late-stage Parkinson’s disease.

entrectinib

Company: Ignyta, Inc.
Treatment for: Neuroblastoma

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

nebivolol and valsartan

Company: Forest Laboratories, Inc.
Treatment for: Hypertension

Nebivolol/Valsartan is an investigational fixed dose combination in development for the treatment of hypertension.

Translarna (ataluren)

Company: PTC Therapeutics, Inc.
Treatment for: Duchenne Muscular Dystrophy

Translarna (ataluren) is a protein restoration therapy in development for the treatment of nonsense mutation Duchenne muscular dystrophy (nmDMD).

Uptravi (selexipag)

Company: Actelion Ltd.

Uptravi (selexipag) is a potent, orally available, selective IP prostacyclin receptor agonist in development for the treatment of pulmonary arterial hypertension.

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.

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.

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).

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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