Priority Review for Melinta's anti-infective

Melinta Therapeutics Inc. (New Haven, Conn.) said FDA accepted and granted Priority Review to NDAs for IV and oral Baxdela delafloxacin to treat acute bacterial skin and skin structure infections (ABSSSIs). The PDUFA date is June 19.

Baxdela has Qualified Infectious Disease Product (QIDP) and Fast Track designations from FDA to treat ABSSSIs and community-acquired bacterial pneumonia (CABP)...