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Reuters Health Information (2013-01-09): FDA seeks more time to review drug for hepatitis C

Regulatory

FDA seeks more time to review drug for hepatitis C

Last Updated: 2013-01-09 15:25:16 -0400 (Reuters Health)

(Reuters) - Idenix Pharmaceuticals Inc said the U.S. health regulator had informed the company that it would need more time to conduct a safety review of Idenix's hepatitis C drug.

The company said on its website that the U.S. Food and Drug Administration had conveyed the need for additional time earlier this month.

Idenix said it submitted data to the FDA in December.

The FDA had placed the drug, IDX184, on a partial clinical hold last August, citing adverse cardiac events seen in rival Bristol-Myers Squibb Co's hepatitis C drug, BMS-986094.

Idenix cannot enroll patients in further studies until it gets FDA clearance for the trial design. The company now expects a response in the first quarter of 2013.

 
 
 
 
                 
 
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