UPDATE 1-Theravance says FDA to review response on antibiotic

Wed Mar 5, 2008 6:17pm EST

(Adds details, share movement)

March 5 (Reuters) - Theravance Inc (THRX.O) said U.S. health regulators accepted for review the company's complete response to the approvable letter on the antibiotic telavancin, used for the treatment of complicated skin infections.

The U.S. Food and Drug Administration has now set a Prescription Drug User Fee Act (PDUFA) target date of July 21, 2008 to reach a decision.

Shares of the company rose 11 percent to $13.55 in trading after the bell.

On Monday, Theravance said it had been notified by the FDA about further evaluation of additional study sites by the regulator due to data issues.

The FDA has now indicated that it does not expect to take final action on telavancin before completing the evaluation, the company said in a statement.

Theravance is collaborating with Japan's Astellas Pharma Inc (4503.T) on U.S. marketing of the drug for the first three years.

(Reporting by Aditi Samajpati and Niveditha Ravi in Bangalore; Editing by Anil D'Silva)

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