St. Louis -- U.S. Food and Drug Administration officials and the U.S. Marshals Service say they've seized $24.2 million worth of unapproved new drugs.
The drugs were confiscated Wednesday from the KV Pharmaceutical Co. of St. Louis. Agents acted after U.S. 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 FDA said the seizure followed an inspection of several plants where investigators found the company was not complying with an FDA enforcement notice.
"The FDA is committed to taking enforcement action against firms that circumvent the drug approval process," said Dr. Janet Woodcock, director of the 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."
Copyright 2008 by United Press International.
Post new comment