FDA ups enforcement on marketed unapproved drugs, as KV draws seizure.

Inspection Monitor | August 1, 2008| | Copyright

FDA is placing stronger emphasis on compliance enforcement on manufacturers that produce unapproved drugs, which account for approximately two percent of the 3.6 billion prescriptions filled in the United States annually, officials announced July 17.

And, just 13 days later on July 30, FDA made good on its promise, by initiating a seizure of about $24 million in unapproved medications from KV Pharmaceutical Co., St. Louis.

According to an agency announcement, the confiscation followed an investigation of several KV Pharmaceutical plants, where federal agents ...

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