Pharmaceutical News and Articles

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.

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

Latest New Drug Applications


cladribine Tablets

Company: Merck Serono

Treatment for: Multiple Sclerosis

Cladribine Tablets is an investigational oral formulation of cladribine under review as a therapy for reducing relapses in people with relapsing forms of multiple sclerosis (MS).


Zalbin (albinterferon alfa-2b)

Company: Human Genome Sciences, Inc.

Treatment for: Chronic Hepatitis C

Zalbin (albinterferon alfa-2b) is a genetic fusion of human albumin and interferon alfa in development for the treatment of chronic hepatitis C.


Intermezzo (zolpidem tartrate) Sublingual Tablets

Company: Transcept Pharmaceuticals, Inc.

Treatment for: Insomnia

Intermezzo is a low dose, buffered, sublingual formulation of zolpidem intended to be the first prescription sleep aid to be indicated for use as-needed for the treatment of insomnia when a middle of the night awakening is followed by difficulty returning to sleep.


Hexvix (hexaminolevulinate)

Company: PhotoCure ASA

Treatment for: Diagnostic

Hexvix (hexaminolevulinate) is a diagnostic agent in development for the detection of papillary bladder cancer using fluorescence cystoscopy.


Provenge (sipuleucel-T) - formerly APC8015

Company: Dendreon Corporation

Treatment for: Prostate Cancer

Provenge (sipuleucel-T) is an investigational active cellular immunotherapy (ACI) in late-stage clinical development for the treatment of patients with metastatic castrate-resistant prostate cancer.


Brilinta (ticagrelor)

Company: AstraZeneca

Treatment for: Acute Coronary Syndrome

Brilinta (ticagrelor) is an investigational oral antiplatelet treatment for the reduction of major adverse cardiac events in patients with acute coronary syndrome (ACS).


naproxcinod

Company: NicOx S.A.

Treatment for: Osteoarthritis

Naproxcinod is the first in a new class of anti-inflammatory agents known as CINODs (Cyclooxygenase-Inhibiting Nitric Oxide Donators) in development for the relief of the signs and symptoms of osteoarthritis.


Lumizyme (alglucosidase alfa)

Company: Genzyme Corporation

Treatment for: Pompe disease

Lumizyme (alglucosidase alfa) is under review for the treatment of Pompe disease.


Exalgo (hydromorphone) Extended Release Tablets

Company: Covidien

Treatment for: Pain

Exalgo (hydromorphone) is an investigational once-a-day extended release opioid formulation for relief for of moderate to severe pain in opioid tolerant patients.


ABthrax (raxibacumab)

Company: Human Genome Sciences, Inc.

Treatment for: Anthrax

ABthrax (raxibacumab) is a human monoclonal antibody drug in development for the treatment of inhalation anthrax.


Acetavance (acetaminophen) Intravenous Injection

Company: Cadence Pharmaceuticals, Inc.

Treatment for: Pain, Fever

Acetavance (intravenous acetaminophen) is an investigational product for the treatment of acute pain and fever in adults and children.


Omapro (omacetaxine mepesuccinate)

Company: ChemGenex Pharmaceuticals

Treatment for: Chronic Myelogenous Leukemia

Omapro (omacetaxine mepesuccinate) is a first-in-class small molecule drug in development for the treatment of imatinib-resistant chronic myeloid leukemia (CML) patients with the T315I mutation.


tesamorelin

Company: Theratechnologies

Treatment for: HIV-Associated Lipodystrophy

Tesamorelin is an analogue of the growth hormone releasing factor proposed for the treatment of excess abdominal fat in HIV patients with lipodystrophy.


pirfenidone

Company: InterMune, Inc.

Treatment for: Idiopathic Pulmonary Fibrosis

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).


velaglucerase alfa

Company: Shire plc

Treatment for: Gaucher Disease

Velaglucerase alfa is an enzyme replacement therapy in development for the treatment of Gaucher Disease.


toremifene

Company: GTx, Inc.

Treatment for: Prevention of Fractures

Toremifene is an oral selective estrogen receptor modulator in development for the prevention of bone fractures in men with prostate cancer on androgen deprivation therapy.




aztreonam lysine for Inhalation

Company: Gilead Sciences, Inc.

Treatment for: Pneumonia with Cystic Fibrosis

Aztreonam lysine for inhalation is an investigational therapy in development for people with cystic fibrosis (CF) who have pulmonary Pseudomonas aeruginosa infection.


QAB149 (indacaterol)

Company: Novartis

Treatment for: Chronic Obstructive Pulmonary Disease

QAB149 (indacaterol) is an investigational once-daily bronchodilator for the treatment of adult patients with chronic obstructive pulmonary disease (COPD).

More...

New Drug Applications Archive

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