Melinta Therapeutics reports that the 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 indicates that the FDA has deemed the applications sufficiently complete to allow a substantive review.

“Baxdela, if approved, represents a potentially attractive monotherapy treatment option for the nearly 3 million patients hospitalized annually in the U.S. with serious skin infections,” stated Eugene Sun, M.D., Melinta’s Chief Executive Officer.