FDA accepts sBLA for Baxdela to treat adult patients with community-acquired bacterial pneumonia
Melinta Therapeutics, Inc has announced the FDA has accepted a supplemental New Drug Application (sNDA) for Baxdela (delafloxacin) for priority review. The sNDA filing seeks to expand the current indication for Baxdela to include adult patients with community-acquired bacterial pneumonia (CABP). The FDA granted priority review status based on the previous Qualified Infectious Disease Product (QIDP) designation, which provides certain incentives for the development of antibacterial and antifungal treatments for serious or life-threatening infections. Through this process, the FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date (proposed review deadline) of October 24, 2019.
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