FDA Approves Vancomycin Hydrochloride Oral Liquid Therapy for CDAD

JANUARY 29, 2018
Officials with the FDA have approved vancomycin hydrochloride (Firvanq, CutisPharma) for oral solution for the treatment of Clostridium difficile associated diarrhea (CDAD) and enterocolitis caused by Staphylococcus aureus, including methicillin-resistant strains, according to a press release.

The vancomycin hydrochloride oral solution will be available in 25 mg/mL and 50 mg/mL strengths in 150 mL and 300 mL sizes. The availability of an oral liquid therapy is expected to improve patient access and reduce pharmacist burden of having to compound liquid formulations.

“As a practicing infectious disease physician treating many patients with CDAD, having an FDA-approved vancomycin oral liquid formulation that is affordable and accessible to my patients is very beneficial,” Stuart Johnson, MD, Loyola University Medical Center, said in the press release.

CutisPharma anticipates Firvanq to be launched on April 2, 2018. The product will replace CutisPharma’s FIRST Vancomycin Unit-of-Use Compounding Kit.


CutisPharma announces FDA approval of Firvanq for treatment of Clostridium difficile associated diarrhea (CDAD) and Staphylococcus Aureus Colitis [news release]. . Accessed January 29, 2018.