Cubist announced that the FDA has accepted the New Drug Application (NDA) for tedizolid phosphate (TR-701) with Priority Review for the treatment of acute bacterial skin and skin structure infections (ABSSSI).
Tedizolid phosphate is an investigational oxazolidinone being developed for both IV and oral administration for the treatment of serious Gram-positive infections, including those caused by methicillin-resistant Staphylococcus aureus (MRSA). The NDA submission is based on data from two global Phase 3 clinical studies of tedizolid in ABSSSI, which met the primary and secondary endpoints.
The FDA designated tedizolid as a Qualified Infectious Disease Product (QIDP) for its indications of ABSSSI, as well as hospital-acquired bacterial pneumonia, and ventilator-associated bacterial pneumonia.
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