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.

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.

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.

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.