Lupin receives USFDA approval for Mirabegron Extended-Release Tablets
Capital MarketLupin 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).
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