CutisPharma confirms FDA’s sanction of FIRVANQ for Clostridium difficile

U.S FDA has sanctioned CutisPharma’s FIRVANQ (vancomycin hydrochloride) for oral solution, for the treatment of Clostridium difficile associated diarrhea and enterocolitis caused by Staphylococcus aureus, including methicillin-resistant strains.

Neal I. Muni, MD, MSPH, Chief Executive Officer of CutisPharma said “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.”

FIRVANQ set to replace CutisPharma’s FIRST®-Vancomycin Unit-of-Use Compounding 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 25 mg/mL and 50 mg/mL strengths in convenient 150 mL and 300 mL sizes.

Image Source: CutisPharma