FDA approves Orbactiv

FDA approved an NDA from The Medicines Co. (NASDAQ:MDCO) for Orbactiv oritavancin to treat acute bacterial skin and skin structure infections (ABSSSIs) caused by Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA). Oritavancin has Qualified Infectious Disease Product (QIDP) designation from FDA for ABSSSI. The designation qualifies oritavancin for an additional five years of market exclusivity.

The drug is under review in Europe to treat complicated skin and skin tissue infections (cSSTIs) caused by Gram-positive bacteria, including MRSA. The Medicines Co. gained the semi-synthetic lipoglycopeptide antibiotic through its 2009 acquisition of Targanta Therapeutics Corp. ...