UPDATE 2-DoJ files suit against KV Pharma

Mon Mar 2, 2009 11:23pm GMT
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* DoJ says United States files suit against co

* DoJ says FDA inspection finds significant violations (Recasts; adds details, background; updates share movement)

BANGALORE, March 2 (Reuters) - The U.S. Department of Justice said it sued KV Pharmaceutical Co (KVa.N: Quote, Profile, Research) (KVb.N: Quote, Profile, Research) to block the drugmaker from making and distributing adulterated and unapproved drugs.

The DoJ said the U.S. Food and Drug Administration's inspection of the company's facilities between December and February found that KV Pharmaceutical committed "significant violations" of the FDA's manufacturing guidelines and continued to manufacture unapproved drugs.

Products recalled over the last few months by the company's units -- Ther-Rx and Ethex Corp -- would be destroyed, it added.

The DoJ also said the company agreed to the injunction in a consent decree. Earlier in the day, KV Pharmaceuticals said it would not market its products until it satisfied certain measures mentioned by the regulators in the decree.

Under the decree, the company cannot resume manufacturing until an independent expert inspects and certifies that it is in compliance with the FDA guidelines. The company would also need a written notification from the FDA that it can resume operations.

The maker of women's healthcare products and pharmaceutical ingredients also said that the decree allowed it to request manufacturing and marketing of certain products before the FDA clears the company to resume full operations.

"Predicting the timing for the return and the ultimate product assortment that we will market are presently very difficult due to the range of variables that must be managed," said the company in a statement.  Continued...

 
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