Tedizolid phosphate regulatory update

On Dec. 30, 2013, Cubist said FDA accepted and granted Priority Review to an NDA for tedizolid to treat acute bacterial skin and skin structure infections (ABSSSI). The PDUFA date is June 20. The NDA covers IV and oral formulations of tedizolid, which both have Qualified Infectious Disease Product (QIDP) designation from FDA to treat ABSSSI and hospital-acquired/ventilator-associated bacterial pneumonia (HABP/VABP). The designations make the antibiotic eligible for an additional 5 years of market exclusivity, if approved. ...