new drug application


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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

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

new drug application

See NDA.

new drug application

,

NDA

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 ?
The company's New Drug Application submission is based mainly on data from the 62 patient epithelioid sarcoma cohort of its ongoing Phase two study of tazemetostat.
The United States Food and Drug Administration (FDA) has approved the New Drug Application for Australia-based Mayne Pharma Group Limited's (ASX: MYX) Tolsura (SUBA-itraconazole) 65mg capsules, it was reported yesterday.
M2 PHARMA-April 20, 2018-Veloxis Pharmaceuticals reports acceptance of supplemental New Drug Application by US FDA for ENVARSUS XR
M2 EQUITYBITES-April 4, 2018-Alkermes's new drug application for ALKS 5461 rejected by US FDA
Tokyo, Japan, Dec 26, 2005 - (JCN) - Astellas Pharma announced on December 26 that its US subsidiary Astellas Pharma US has filed a New Drug Application for FK506 modified release formulation (tacrolimus), its proprietary immunosuppressant, with the US Food and Drug Administration (FDA).
M2 PHARMA-April 4, 2018-Alkermes's new drug application for ALKS 5461 rejected by US FDA
M2 EQUITYBITES-March 1, 2018-US Food and Drug Administration rejects Celgene's new drug application for ozanimod
Tokyo, Japan, Dec 21, 2005 - (JCN) - Eisai has announced that its US subsidiary Eisai Medical Research resubmitted a supplemental new drug application (sNDA) for Aricept, the company's proprietary agent for treating severe Alzheimer's disease, to the US Food and Drug Administration (FDA) as of December 16.
M2 PHARMA-March 1, 2018-US Food and Drug Administration rejects Celgene's new drug application for ozanimod
M2 EQUITYBITES-February 23, 2018-US FDA accepts for filing Acorda Therapeutics' new drug application for Inbrija
M2 PHARMA-February 23, 2018-US FDA accepts for filing Acorda Therapeutics' new drug application for Inbrija
It was reported on Friday that United States-based Gilead Sciences has received priority review from the US Food and Drug Administration for its new drug application of investigational, fixed-dose combination of bictegravir (50mg) (BIC) and emtricitabine/tenofovir alafenamide (200/25mg) (FTC/TAF) for the treatment of HIV.