he 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
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.
1) Gattex (teduglutide)
Company: NPS Pharmaceuticals, Inc.
Treatment for: Short Bowel Syndrome
Company: Alexza Pharmaceuticals, Inc.
Treatment for: Agitation, Schizophrenia, Bipolar Disorder
Company: Protalix BioTherapeutics, Inc.
Treatment for: Gaucher Disease
Company: QRxPharma Limited
Treatment for: Pain
5) Mirabegron
Company: Astellas Pharma Inc.
Treatment for: Overactive Bladder
Company: Novartis
Treatment for: Gouty Arthritis
Company: NuPathe Inc.
Treatment for: Migraine
8) Avanafil
Company: Vivus, Inc.
Treatment for: Erectile Dysfunction
Company: Discovery Laboratories, Inc.
Treatment for: Respiratory Distress Syndrome
10) Vismodegib
Company: Genentech
Treatment for: Basal Cell Carcinoma
Company: ApoPharma Inc.
Treatment for: Transfusional Iron Overload
Company: Orexigen Therapeutics, Inc.
Treatment for: Obesity
13) IMGN529
Treatment for: non-Hodgkin's Lymphoma
IMGN529 is a CD37-targeting TAP compound in development for the treatment of non-Hodgkin's Lymphoma and other B-cell malignancies.
14) MenHibrix
Company: GlaxoSmithKline
Treatment for: Haemophilus influenzae Prophylaxis, Meningococcal Meningitis Prophylaxis
Company: Chelsea Therapeutics International, Ltd.
Treatment for: Neurogenic Orthostatic Hypotension
Company: Adventrx Pharmaceuticals, Inc.
Treatment for: Non-Small Cell Lung Cancer
Company: Yaupon Therapeutics, Inc.
Treatment for: Mycosis Fungoides
18) Ridaforolimus
Company: Merck
Ridaforolimus is an investigational oral mTOR inhibitor under development for the treatment of metastatic soft-tissue or bone sarcomas in patients who had a favorable response to chemotherapy.
Company: Transcept Pharmaceuticals, Inc.
Treatment for: Insomnia
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