Drug Development

FDA issues follow-up statement on unapproved long-acting Guaifenesin

Published in Biotech Business Week, March 31st, 2003

Adams Laboratories, Inc., commented on the U.S. Food and Drug Administration's (FDA) follow-up statement to the agency's October 2002 warning letter for manufacturers and distributors of unapproved long-acting, single-entity guaifenesin.

Specifically, in July 2002, the FDA approved a new drug application (NDA) for a single ingredient guaifenesin 600 mg extended release drug product Mucinex, produced by Adams Laboratories. Following this approval, the FDA reviewed the marketing status of all strengths of single ingredient extended release guaifenesin products and determined that all such unapproved products should no longer be marketed in light of the existence of an...

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Source: Biotech Business Week (2003-03-31)

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