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    Home > Strides receives USFDA approval for Lidocaine Ointment

    Strides receives USFDA approval for Lidocaine Ointment

    Chemical Weekly 2018-12-28


    Strides Pharma Science Ltd. has announced that its step-down, wholly-owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received approval for Lidocaine Ointment USP 5% from the USFDA. This is a generic version of Xylocaine Ointment of AstraZeneca Pharmaceuticals LP.

    According to IQVIA MAT data, the US market for Lidocaine Ointment USP 5% is approximately $50-mn. The product will be marketed by Strides Pharma Inc. in the US market and will be launched immediately.

    Strides Pharma Inc has 80 cumulative ANDA filings with USFDA of which 54 ANDAs have been approved as of date and 26 are pending approval.

    Strides Vivimed JV receives approval for albendazole tablets

    In another development, Strides has announced that its 50:50 JV Strides Vivimed Pte. Ltd., Singapore has received approval for Albendazole Tablets USP 200 mg from the US FDA. This is the second generic approval by the USFDA for Albendazole Tablets.

    The drug to be launched by Strides is a generic version of Albenza Tablets of Amneal Pharmaceuticals, Inc., and had annual sales of approximately $100-mn.

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