Strides receives USFDA approval for flucytosine capsules
Product approval from flagship facility in Bengaluru; to be marketed by Strides Pharma Inc in the US market
Strides Pharma Global, Singapore has received approval for flucytosine capsules USP, 250 mg and 500 mg from the United States Food and Drug Administration (USFDA). The product is a generic version of ancobon capsules, 250 mg and 500 mg, of Bausch Health US, LLC.
According to IQVIA MAT data, the US market for flucytosine capsules USP, 250 mg and 500 mg is approximately $45 million. The product will be manufactured at the company’s flagship facility at Bengaluru and will be marketed by Strides Pharma Inc in the US market.
The company has 123 cumulative ANDA filings with USFDA, of which 86 ANDAs have been approved and 37 are pending.
Flucytosine capsule is indicated only in the treatment of serious infections caused by susceptible strains of candida (septicemia, endocarditis and urinary system infections) and/or cryptococcus (meningitis and pulmonary infections).
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