Drug Development

FDA Takes Action to Stop Marketing of Unapproved Timed-Release Guaifenesin Drug Products

Published in Drug Law Weekly, June 12th, 2007

The U.S. Food and Drug Administration (FDA) today announced its intention to take action against companies that market unapproved drug products in timed-release dosage form that contain guaifenesin, a substance commonly used in medicines to relieve cough and cold symptoms by stimulating removal of mucous from the lungs.

Approximately 20 firms make timed-release products containing guaifenesin that have not undergone FDA review and as a result are considered by the agency to be unapproved drugs.

"Today's action is another example of our commitment to ensure all drugs marketed in the United States that require FDA approval have that approval," said...

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Source: Drug Law Weekly (2007-06-12)

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