Strides receives USFDA approval for Flucytosine capsules

Strides Pharma Science Limited has announced that its step-down wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received approval for Flucytosine capsules USP, 250 mg and 500 mg, from the United States Food & Drug Administration (USFDA). The product is a generic version of Ancobon capsules, 250 mg and 500 mg, of Bausch Health US, LLC. 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). The company has 123 cumulative ANDA filings with USFDA, of which 86 ANDAs have been approved and 37 are pending approval.

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