Firvanq Approved for C. difficile-Associated Diarrhea, S. aureus Colitis

FDA-approved vancomycin oral liquid
FDA-approved vancomycin oral liquid

CutisPharma announced that the Food and Drug Administration (FDA) has approved Firvanq (vancomycin HCl) for oral solution for the treatment of Clostridium difficile-associated diarrhea and enterocolitis caused by Staphylococcus aureus, including methicillin-resistant strains.

Firvanq oral solution will replace CutisPharma's FIRST-Vancomycin Unit-of-Use Compounding Kit, which was used by pharmacists to compound vancomycin oral liquid. Vancomycin, a glycopeptide antibiotic, works primarily through inhibition of cell wall biosynthesis. In addition, it alters bacterial-cell-membrane permeability and RNA synthesis. Vancomycin is not active in vitro against gram-negative bacilli, mycobacteria, or fungi.

"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 Dr. Stuart Johnson, Loyola University Medical Center. 

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Firvanq will be available as 25mg/mL and 50mg/mL strengths in 150mL and 300mL sizes. It is anticipated to launch on April 2, 2018. 

For more information call (800) 461-7449 or visit Cutispharma.com.