FDA siezes more than $24 million in unapproved drugs

ROCKVILLE, Md. The Food and Drug Administration on Wednesday executed its second product seizure in a week, having confiscated $24.2 million worth of unapproved new drugs from KV Pharmaceutical Company of St. Louis, Mo. after United States Attorney Catherine Hanaway filed a civil forfeiture suit and obtained a warrant to seize the unapproved new drug products being made by KV Pharmaceutical.

The seizure followed an inspection of several of the company’s plants where FDA investigators found that the company was not complying with an FDA enforcement notice as well as manufacturing unapproved new drugs such as products for cough, cold, topical wound healing, skin bleaching, and gastrointestinal conditions, as well as narcotic drug products.

“The FDA is committed to taking enforcement action against firms that circumvent the drug approval process,” stated Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research. “Consumers need to be confident that the drugs and medical products they use are safe and effective, and the FDA will take the necessary measures to ensure safety and effectiveness throughout the lifecycle of the product, including keeping the product from reaching the marketplace.”

Earlier this year, FDA had found KV Pharmaceutical was violating a May 29, 2007 edict that required companies to stop manufacturing all timed-release drug products containing guaifenesin, including combination drug products in which guaifenesin is in immediate release form, but another ingredient in the combination drug product is in timed-release form, because they are unapproved new drugs.

Wednesday’s seizure falls only one week after the FDA confiscated $74,000 in Xiadafil VIP tablets, Lots 6K029 and 6K209-SEI, distributed by SEI Pharmaceuticals of Miami, Fla.