US FDA approves Lupin’s Mirabegron extended-release tablets

The US Food and Drug Administration (FDA) has approved Lupin’s 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, according to a statement from Lupin.

The product will be manufactured at Lupin’s facility in Nagpur, the statement added.