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Published on May 31, 2007 by Edgar Snyder

FDA Halts Production on Cough Medicines

Guaifenesin

The Food and Drug Administration (FDA) has ordered companies that produce cough medicine containing guaifenesin in timed-release formula to cease production and shipping before the end of 2007. Guaifenesin is a substance that stimulates the removal of mucous from the lungs in cough and cold sufferers.

About 20 different companies manufacture extended-release guaifenesin products without official FDA approval. Often, these products contain other cough and cold suppressants in combination with guaifenesin. Production must be ceased before the end of August, and shipping must end before the last days November.

The FDA requires that all timed-release medications undergo review to ensure their safety of dosage and effectiveness. This current order does not apply to immediate-release medication with guaifenesin.

Please note: All of our lawyers are licensed to practice in the state of Pennsylvania. We also have lawyers licensed to practice in Ohio and West Virginia, and we associate with experienced attorneys in other states. In addition, all drug-related litigation may involve co-counsel.

Source: "FDA Takes Action to Stop Marketing of Unapproved Timed-Release Guaifenesin Drug Products." FDA Press Release. May 25, 2007.
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