FDA: Vancomycin Liquid Oral Treatment Approved for C diff-Associated Diarrhea
Firvanq is approved to treat C diff-associated diarrhea and enterocolitis due to S aureus.
The US Food and Drug Administration has approved Firvanq™ (vancomycin hydrochloride; CutisPharma, Inc) to treat Clostridium difficile-associated diarrhea and enterocolitis resulting from Staphylococcus aureus.
Firvanq is expected to launch on April 2, 2018. The oral solution will replace CutisPharma's FIRST®-Vancomycin Unit-of-Use compounding kit for preparation of vancomycin oral liquid therapy.
“Availability of an FDA-approved vancomycin oral liquid treatment will effectively allow any pharmacy to stock this therapy, and hopefully encourage third-party payer reimbursement, significantly improving accessibility and convenience for patients,” said Stuart Johnson, MD, of Loyola University Medical Center.
Firvanq will be available in 25-mg/mL and 50-mg/mL doses and 150-mL and 300-mL sizes.
CutisPharma announces FDA approval of FIRVANQ™ [news release]. Wilmington, MA: CutisPharma, Inc. http://cutispharma.com/cutispharma-announces-fda-approval-firvanq/. Published January 29, 2018. Accessed January 29, 2018.