Melinta Therapeutics announced the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Applications (NDAs) for IV and oral Baxdela™ (delafloxacin) for filing and granted Priority Review status to both NDAs. The acceptance of the NDAs indicates that the FDA has deemed the applications sufficiently complete to allow a substantive review. Baxdela is an investigational anionic fluoroquinolone with a broad spectrum of antimicrobial activity, including activity against methicillin-resistant Staphylococcus aureus (MRSA). Melinta submitted NDAs for Baxdela in October for the treatment of patients with acute bacterial skin and skin structure infections (ABSSSI). Baxdela has been designated a Qualified Infectious Disease Product (QIDP) by the U.S.FDA, which provides for Priority Review. Consistent with the priority review timelines, Melinta has been informed that the FDA has set a Prescription Drug User Fee Act (PDUFA) target date of June 19, 2017, by which time it expects to provide the company with a regulatory decision.