Lupin receives approval from U.S. FDA for Mirabegron Extended-Release Tablets

Global pharma major Lupin Limited (Lupin) today announced that it has received approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA), Mirabegron Extended-Release Tablets, 25 mg and 50 mg, to market a generic equivalent of Myrbetriq® Extended-Release Tablets, 25 mg and 50 mg, of Astellas Pharma Global Development, Inc. The product will be manufactured at Lupin's facility in Nagpur, India.

Mirabegron Extended-Release Tablets, 25 mg and 50 mg, (RLD Myrbetriq®) had estimated annual sales of USD 2403 million in the U.S. (IQVIA MAT June 2022).

Source : Equity Bulls

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Lupin Approval USFDA ANDA Mirabegron ExtendedReleaseTablets