FDA Has 'Outstanding Issues' With Theravance Drug

Morningstar "Televancin is a once-daily injectable antibiotic that would be used to treat skin infections, including those caused by resistant bacteria like methicillin- resistant staphylococcus aureus, or MRSA.
In October the FDA issued a so-called approvable letter for televancin, suggesting it needed a re-analysis of clinical data and the resolution of manufacturing issues at a third-party manufacturer that was not specifically related to televancin. The FDA said it continues to review televancin's application but didn't give a timetable for completion of the review."