FDA, Justice Seize GSK's Paxil CR, Avandamet Over Manufacturing Violations

The FDA and the Justice Department have halted the distribution of GlaxoSmithKline's (GSK) antidepressant Paxil CR and diabetes drug Avandamet because of ongoing concerns about the manufacturing quality of the products.

U.S. marshals seized stocks of the drugs at GSK's manufacturing facility in Puerto Rico and at distribution facilities in Knoxville, Tenn., and Puerto Rico. The FDA said it took the action because several inspections of the Puerto Rico plant, where the products have been made since 2002, revealed significant violations of the agency's current good manufacturing practice regulations.

The seizure is expected to result in a shortage of the drugs, GSK said, including all strengths of Paxil CR (paroxetine HCl controlled release) tablets and Avandamet (rosiglitazone maleate/metformin HCl) in 1-, 2- and 4-mg strength tablets. Paxil CR had U.S. sales of $710 million in 2004, while Avandamet's sales last year were under $400,000, according to GSK. A company spokeswoman would not comment on the financial impact of the FDA's action.

For more information on the FDA action, go to http://www.fda.gov/bbs/topics/news/2005/NEW01162.html (http://www.fda.gov/bbs/topics/news/2005/NEW01162.html).

()A href="http://www.fdanews.com/pub/did"