Melinta: FDA Accepts Application for Bacterial Pneumonia Candidate

Application Seeks to Expand Label to Include an Indication and Phase III Data for the Treatment of Adult Patients with Community-Acquired Bacterial Pneumonia (CABP) ~

~ PDUFA Date Set for October 24, 2019 ~

Melinta Therapeutics, Inc. (NASDAQ: MLNT), a commercial-stage company focused on the development and commercialization of novel antibiotics to treat serious bacterial infections, today announced the U.S. Food and Drug Administration (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.

https://www.marketscreener.com/MELINTA-THERAPEUTICS-INC-55126386/news/Melinta-Therapeutics-Announces-U-S-FDA-Acceptance-of-Supplemental-New-Drug-Application-for-BAXDELA-28780345/