US FDA approves CDAD drug Firvanq

The US Food and Drug Administration has approved Firvanq (vancomycin hydrochloride) for oral solution, for the treatment of Clostridium difficile associated diarrhea and enterocolitis caused by Staphylococcus aureus, including methicillin-resistant strains, developed by US privately-held drugmaker CutisPharma.

"We are pleased to announce the FDA approval of Firvanq," said Neal Muni, chief executive of CutisPharma. "Firvanq's approval is an important step forward to providing patients the only FDA-approved vancomycin oral liquid treatment option for Clostridium difficile associated diarrhea, a life-threatening condition that affects over a half-million patients in the United States annually."

Upon its launch, which is targeted to be April 2, 2018, Firvanq will replace CutisPharma's FIRST-Vancomycin Unit-of-Use Com Firvanq pounding Kit, which has been available to pharmacists that need a convenient, accurate, and compliant way to compound vancomycin oral liquid therapy. Firvanq will be commercially available in 25mg/mL and 50mg/mL strengths in convenient 150mL and 300mL sizes.