FDA: New Drug Approved for C difficile Diarrhea

The US Food and Drug Administration (FDA) has approved the oral liquid therapy FIRVANQ (vancomycin hydrochloride) for the treatment of Clostridium difficile-associated diarrhea (CDAD) and Staphylococcus aureus-associated enterocolitis.

FIRVANQ will be available in 25 mg/mL and 50 mg/mL strengths in 150 mL and 300 mL sizes. It is set to be launched on April 2, 2018, and will replace CutisPharma’s FIRST-Vancomycin Unit-of-Use Compounding Kit.
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“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,” said Stuart Johnson, MD, of Loyola University Medical Center, in a press release.

—Christina Vogt

Reference:

CutisPharma announces FDA approval of FIRVANQ [press release]. Wilmington, MA. CutisPharma. January 29, 2018. http://cutispharma.com/cutispharma-announces-fda-approval-firvanq/. Accessed on January 31, 2018.