Melinta Therapeutics Announces U.S. FDA Acceptance of Supplemental New Drug Application for BAXDELA® (delafloxacin) for the Treatment of Community-Acquired Bacterial Pneumonia
MELINTA THERAPEUTICS INC (MLNT)
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Source: GlobeNewswire
~ 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 ~ MORRISTOWN, N.J., June 19, 2019 (GLOBE NEWSWIRE) -- 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-threateni
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