new drug application

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Related to new drug application: abbreviated new drug application

New Drug Application (NDA),

a document whereby a pharmaceutical manufacturer or its agent requests permission from the United States Food and Drug Administration (FDA) for a license to market a drug for one or more specified indications; besides a chemical and pharmacologic description of the drug, the application must show the results of clinical trials conducted with respect to the indication for which a license is requested.

New Drug Application

An application to FDA for a licence to market a new drug in the USA.

new drug application

See NDA.

new drug application



An application requiring approval by the Food and Drug Administration before any new drug is marketed to the general public. Before approval, the manufacturer must provide the FDA with scientifically acceptable evidence of the new drug's safety and efficacy.
References in periodicals archive ?
Lee to the PhytoMedical team, who brings us clinical expertise in pharmacology and experience with new drug applications and abbreviated new drug applications to the FDA," explained Mr.
According to the available information, Actavis believes it may be a 'first applicant' to file an Abbreviated New Drug Application for the generic version of Absorica(r), and, should its Abbreviated New Drug Application be approved, may be entitled to 180 days of generic market exclusivity.
A Bio-E-Gel new drug application (NDA) was submitted to the FDA in the first quarter 2006.
If the requisite statistical parameters are achieved, GTx will proceed with the filing of a New Drug Application.
Synovics intends to file Abbreviated New Drug Applications (ANDAs) with the FDA for its oral controlled-release generic drugs.
This news release may contain forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including statements regarding the scheduling of an FDA Advisory Committee meeting to consider our New Drug Application for FACTIVE for the treatment of ABS and the availability of additional information, the scheduled date for action by the FDA on our pending New Drug Application, the advancement of the commercialization of FACTIVE and TESTIM, and the pursuit of company milestones, including initiating the Ramoplanin Phase III clinical development program and securing additional marketed products through licensing, acquisition or co-promotion.
com AVANIR's lead product candidate, Neurodex(TM) for the treatment of involuntary emotional expression disorder, is the subject of a New Drug Application under priority review with the FDA.
Its products are used by pharmaceutical, biotechnology and medical device companies to create new drug applications, reports, proposals and technical documentation.
IHI president/ceo Mason Slaine said that IHI "now has the most complete suite of offerings related to new drug applications (NDAs) of any company in the world.
M2 EQUITYBITES-August 22, 2014-Lannett signs contract to acquire abbreviated new drug applications for two generic pharmaceutical products
M2 PHARMA-August 22, 2014-Lannett signs contract to acquire abbreviated new drug applications for two generic pharmaceutical products
These new capabilities will make it easier for pharmaceutical companies to analyze genetic data and incorporate this analysis into new drug applications.