Melinta Therapeutics Announces U.S. FDA Approval of Supplemental New Drug Application for BAXDELA® (delafloxacin) for the Treatment of Community-Acquired Bacterial Pneumonia (CABP)
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 approved BAXDELA® (delafloxacin) for the treatment of adult patients with community-acquired bacterial pneumonia (CABP) caused by designated susceptible bacteria. This supplemental approval follows FDA priority review 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.
AMR NEWS
Your Biweekly Source for Global AMR Insights!
Stay informed with the essential newsletter that brings together all the latest One Health news on antimicrobial resistance. Delivered straight to your inbox every two weeks, AMR NEWS provides a curated selection of international insights, key publications, and the latest updates in the fight against AMR.
Don’t miss out on staying ahead in the global AMR movement—subscribe now!