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Drug Approvals Over Time 2007

Published by: PharmaLive

Published: Feb. 7, 2007 - 14 Pages


Table of Contents


The number of new medicines cleared for marketing by FDA (fda.gov) increased last year compared with 2005.


In 2006, 93 new medicines were approved by U.S. regulators according to Med Ad News criteria versus 81 new products approved during the previous year.


In 2004, 113 medicines were given the green light by U.S. regulatory authorities under these criteria.

Abstract

This PharmaLive special report tracks prescription medicines approved for the first time by FDA from 1990 through 2006, and lists the marketer of each product. The medicines were approved by FDA regulators through a new drug application or biologics license application. These medicines include new molecular entities, biotechnology drugs, biologicals, imaging agents, branded generics, and branded formulations of existing products. Excluded from this list are nonbranded generics approved via an abbreviated new drug application, over-the-counter medicines, diagnostic tests, and tentative product approvals.

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