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).
RELATED: Infectious Disease Resource Center
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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