abbreviated new drug application

Abbreviated New Drug Application

A simplified submission to the US Food & Drug Administration (FDA) requesting authorization to market a new  formulation of an existing drug or an investigational drug similar to an already approved drug, for which both its therapeutic indications and formulation were previously approved by the FDA.

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abbreviated new drug application

Pharmacology An application made in the US by a pharmaceutical company requesting authority to market a 'new' drug for which both its therapeutic indications and formulation were previously approved by the FDA in another similar drug. See Me too drug.

McGraw-Hill Concise Dictionary of Modern Medicine. © 2002 by The McGraw-Hill Companies, Inc.

ab·bre·vi·a·ted new drug ap·pli·ca·tion

(ă-brē'vē-ā-tĕd nū drŭg ap'li-kā'shŭn)

A request by a pharmaceutical company to market and sell a pharmaceutical that is essentially the same as another, which has already been granted such approval.

Medical Dictionary for the Health Professions and Nursing © Farlex 2012

abbreviated new drug application

,

ANDA

A formal request to the U.S. Food and Drug Administration to approve a generic drug that is a copy of a patented agent already approved for use.

Medical Dictionary, © 2009 Farlex and Partners