5 January 2017 - Melinta Therapeutics announced today the U.S. FDA has accepted the company’s new drug applications for IV and oral Baxdela (delafloxacin) for filing and granted priority review status to both applications. The acceptance of the applications 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. Melinta submitted applications for Baxdela in October for the treatment of patients with acute bacterial skin and skin structure infections. 

Baxdela has been designated a qualified infectious disease product 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 target date of 19 June 2017, by which time it expects to provide the company with a regulatory decision.

Read Melinta Therapeutics press release