FDA accepts telavancin NDA for HAP

FDA accepted for filing an NDA for telavancin from Theravance Inc. (NASDAQ:THRX) to treat hospital-acquired pneumonia (HAP) caused by Gram-positive bacteria. The PDUFA date is Nov. 26. The acceptance triggers a $10 million milestone payment from partner Astellas Pharma Inc. (Tokyo:4503). In February, Theravance received a complete response letter from FDA for an NDA for the injectable lipoglycopeptide antibiotic to treat complicated skin and skin structure infections (cSSSIs) (See BioCentury Extra, Thursday, Feb. 26, 2009). ...