• Lupin receives tentative U.S. FDA approval for Mirabegron ER Tablets

    • June 27, 2019
    • Posted By : admin
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    Pharma major Lupin Limited (Lupin) has received tentative approval for its Mirabegron Extended Release (ER) Tablets, 25 mg and 50 mg, from the United States Food and Drug Administration (FDA), to market a generic version of Myrbetriq Extended Release Tablets, 25 mg and 50 mg, of Astellas Pharma Global Development Inc. (Astellas).

    Lupin’s Mirabegron ER Tablets, 25 mg and 50 mg, is a generic version of Myrbetriq Extended Release Tablets, 25 mg and 50 mg, of Astellas. It is indicated for the treatment of Overactive Bladder (GAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.

    Mirabegron ER Tablets 25 mg and 50 mg (RLD: Myrbetriq) had annual sales of approximately USD 1501.6 mn in the US (IMS MAT March 2019).

    Shares of LUPIN LTD. was last trading in BSE at Rs.763.5 as compared to the previous close of Rs. 768.3. The total number of shares traded during the day was 69354 in over 2247 trades.

    The stock hit an intraday high of Rs. 774.4 and intraday low of 754.2. The net turnover during the day was Rs. 53085125.

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