Theravance still has no action letter from FDA on telavancin

US biopharmaceuticals firm Theravance says that the Food and Drug Administration has not yet made a decision regarding the New Drug Application for telavancin. The Prescription Drug User Fee Act date for action by FDA was July 21, and as of then, the company had not received an action letter from the agency. Telavancin is a novel, bactericidal, once-daily injectable investigational antibiotic, for the proposed indication to treat complicated skin and skin-structure infections caused by Gram-positive bacteria, including resistant pathogens such as methicillin-resistant Staphylococcus aureus.

The company previously announced that the FDA had indicated that it did not expect to take final action on the telavancin 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 that were cited in the approvable letter received in October, 2007.

"We continue to work diligently with the FDA to resolve the remaining issues on our cSSSI NDA," said Rick Winningham, the firm's chief executive, adding: "we remain confident in the data generated in this program and are committed to bringing the potential benefit of telavancin to those patients suffering from cSSSI and more serious infections such as hospital-acquired pneumonia."