FDA approves treatment for C. diff-associated diarrhea: 3 things to know

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.

More articles on supply chain: 
FDA halts T-cell therapy trial after 3 patients develop brain disease 
Drug prices will be top priority for Azar, says Trump 
Drug spend to jump 7.3% for health systems in 2018: 4 report findings

Copyright © 2024 Becker's Healthcare. All Rights Reserved. Privacy Policy. Cookie Policy. Linking and Reprinting Policy.

 

Featured Whitepapers

Featured Webinars