The FDA on Monday granted approval to CutisPharma's drug Firvanq to treat Clostridium difficile-associated diarrhea and Staphylococcus aureus-associated intestinal inflammation (enterocolitis).
Here are three things to know.
1. Firvanq is a vancomycin hydrochloride oral solution.
2. CutisPharma plans to launch Firvanq April 2. The drug will replace CutisPharma's vancomycin compounding kit, which pharmacists use to compound oral liquid vancomycin therapies.
3. The newly approved drug is meant to improve patient access to oral liquid vancomycin, as there is a limited number of pharmacies that can perform compounding in the outpatient setting.
"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," said Neal Muni, MD, CEO of CutisPharma.
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