The US Food and Drug Administration (FDA) has approved vancomycin hydrochloride for oral solution (Firvanq, CutisPharma) for the treatment of Clostridium difficileassociated diarrhea (CDAD) and enterocolitis caused by Staphylococcus aureus, including methicillin-resistant strains, the company announced.
“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,” Neal I. Muni, MD, chief executive officer of CutisPharma, said in a news release.
Firvanq will be available in 25 mg/mL and 50 mg/mL strengths and will replace CutisPharma’s First-Vancomycin unit-of-use compounding kit.
“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,” Stuart Johnson, MD, of Loyola University Medical Center, Chicago, Illinois, said in the release.
“Patient access is currently limited by the fact that only a select few pharmacies perform compounding in the outpatient setting these days, given the many new regulations in place. 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,” Dr Johnson added.
The target launch date for Firvanq is April 2, 2018.
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