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    • Lupin gets tentative...

    Lupin gets tentative USFDA nod for generic version of Mirabegron ER tablets

    Farhat NasimWritten by Farhat Nasim Published On 2019-06-28T11:10:22+05:30  |  Updated On 16 Aug 2021 5:14 AM GMT

    The approval by the US Food and Drug Administration (USFDA) is for a generic version of Mirabegron ER tablets of strengths 25 mg and 50 mg, Lupin said in a statement.


    New Delhi: Drug maker Lupin Thursday said it has received tentative approval from the US health regulator for a generic version of Mirabegron Extended Release (ER) tablets of Astellas Pharma Global Development Inc used to treat overactive bladder.


    The approval by the US Food and Drug Administration (USFDA) is for a generic version of Mirabegron ER tablets of strengths 25 mg and 50 mg, Lupin said in a statement.


    Also Read: Inflated prices to 1000 per cent; Lupin, Sun Pharma, Dr Reddys, others face lawsuit










    The medicine is indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.








    Citing IMS MAT March 2019 data, Lupin said Mirabegron ER Tablets, 25 mg and 50 mg, had annual sales of approximately USD 1,501.6 mn (about Rs 10,500 crore) in the US.


    Also Read: Lupin recalls over 18000 bottles of Cefdinir for Oral Suspension in US

    Articles Astellas Pharma Astellas Pharma Global Development Inc Beta3-adrenergic agonist generic drug health Healthcare life sciences Mirabegron Mitsubishi UFJ Financial Group overactive bladder pharma pharma news Pharmaceutical industry RTT United States US 
    Source : PTI

    Disclaimer: This site is primarily intended for healthcare professionals. Any content/information on this website does not replace the advice of medical and/or health professionals and should not be construed as medical/diagnostic advice/endorsement or prescription. Use of this site is subject to our terms of use, privacy policy, advertisement policy. © 2020 Minerva Medical Treatment Pvt Ltd

    Farhat Nasim
    Farhat Nasim

      Farhat Nasim joined Medical Dialogue an Editor for the Business Section in 2017. She Covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She is a graduate of St.Xavier’s College Ranchi. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751 To know about our editorial team click here

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