Injectable Antibiotic Gets FDA Approval Letter

Theravance, San Francisco, CA, received a US Food and Drug Administration (FDA) approval letter for televancin, a novel bactericidal, once-daily injectable antibiotic for the treatment of complicated skin and skin structure infections caused by gram-positive bacteria, including methicillin-resistant Staphylococcus aureus. The approval level indicates that televancin’s application is approvable subject to the resolution of current good manufacturing practices compliance issues and submission of revised labeling or reanalyses of clinical data or additional clinical data. In November 2005, Theravance entered into a collaboration with Astellas Pharma, Inc, Deerfield, IL, for the worldwide development and commercialization of televancin, excluding Japan. In July 2006, the collaboration was expanded to include Japan.