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Strides arm and its partner get USFDA nod for hypokalemia treatment drug

The United States Food and Drug Administration (USFDA) has approved the product in the strengths of 10 mEq (750 mg), 15 mEq (1,125 mg), and 20 mEq (1,500 mg), Strides Pharma Science said in a regulatory filing.

April 02, 2019 / 12:07 IST
     
     
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    Drug firm Strides Pharma Science on Tuesday said its step-down wholly-owned subsidiary Vensun Pharmaceuticals, Inc., USA, and its partner Pharmaceutics International, Inc. (Pii), have received approval from the US health regulator for jointly developed Potassium Chloride extended-release tablets.

    The United States Food and Drug Administration (USFDA) has approved the product in the strengths of 10 mEq (750 mg), 15 mEq (1,125 mg), and 20 mEq (1,500 mg), Strides Pharma Science said in a regulatory filing.

    The approved product, used in treatment of patients with hypokalemia, is a generic version of Merck, Inc's Potassium Chloride extended-release tablets, it said.

    Quoting IQVIA MAT data, Strides Pharma Science said the US market for Potassium Chloride extended-release tablets is approximately USD 240 million.

    The product will be manufactured by Pii and will be marketed by Strides in the US market, it said.

    Shares of Strides Pharma Science were trading 0.26 per cent higher at Rs 477.60 apiece on the BSE.

    PTI
    first published: Apr 2, 2019 11:59 am

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