FDA approves another antibiotic for hard-to-treat skin infections
FDA has approved oritavancin (Orbactiv, The Medicines Company) for injection for the treatment of adults with acute bacterial skin and skin structure infections (ABSSSIs) caused by susceptible designated Gram-positive bacteria including methicillin-resistant Staphylococcus aureus (MRSA).
Oritavancin is the first and only antibiotic approved by FDA to treat ABSSSIs with a single, once-only administration. Once fully infused over 3 hours, the oritavancin treatment regimen is complete for patients with skin infections caused by susceptible Gram-positive pathogens.
Oritavancin is the third new antibacterial drug approved by FDA this year to treat ABSSSI. The agency approved dalbavancin (Dalvance, Durata Therapeutics) in May 2014 and tedizolid (Sivextro, Cubist Pharmaceuticals) in June 2014.
It is also the third new drug designated as a Qualified Infectious Disease Product (QIDP) to receive FDA approval. “Under the Generating Antibiotic Incentives Now (GAIN) title of the FDA Safety and Innovation Act, oritavancin was granted QIDP designation because it is an antibacterial or antifungal human drug intended to treat a serious or life-threatening infection,” according to an FDA statement.