Regulatory Issues

FDA issues warnings in the long-acting guaifenesin market

Published in Medical Letter on the CDC and FDA, December 1st, 2002

The U.S. Food and Drug Administration (FDA) has sent warning letters to all manufacturers and distributors of long-acting, single ingredient, guaifenesin, stating that their products must be withdrawn immediately from the market until they submit a new drug application (NDA) or abbreviated new drug application (ANDA) and receive approval by the FDA for marketing, reports Adams Laboratories, Inc.

Adams Laboratories' product, Mucinex, is now the only long-acting, single ingredient, guaifenesin product available in the U.S., the company pointed out. Guaifenesin is marketed for relief of cold and flu symptoms.

The regulatory action came as a result of...

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Source: Medical Letter on the CDC and FDA (2002-12-01)

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