The Anti-Infective Drugs Advisory Committee reviews Durata Therapeutics' (DRTX) dalbavancin and Cubist Pharmaceuticals' (CBST) tedizolid today.
The FDA granted both products priority review status under the less-rigorous "non-inferiority" method.
Dalbavancin is comparable to vancomycin, but it is administered via two IV infusions a week apart and enables the patient to avoid two weeks of hospitalization.
Tedizolid is also comparable to an existing drug but it will be evaluated for hospital-acquired MRSA infections.
Two other antibiotics given the accelerated review have a heightened risk of serious adverse events and/or death.