FDA to Review Theravance's Complete Response for Skin Infection Drug
Posted on: Thursday, 6 March 2008, 09:01 CST
Theravance has said that the FDA has accepted for review the company's complete response to the new drug application approvable letter for telavancin, an investigational antibiotic for the treatment of complicated skin and skin structure infections caused by Gram-positive bacteria.
The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target date of July 21, 2008. The FDA has indicated that it does not expect to take final action on the telavancin new drug application (NDA) prior to completing its further evaluation of study site monitoring and study conduct in the Atlas Phase III program, nor prior to resolution of the manufacturing issues not specifically related to telavancin cited in the approvable letter.
Rick Winningham, CEO of Theravance, said: "We are pleased that the FDA has accepted for review our complete response, which we submitted on January 21, 2008. We are committed to working with the FDA to resolve the remaining issues on our complicated skin and skin structure infections (cSSSI) NDA."
Source: Datamonitor
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