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.
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