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Lupin gets tentative US FDA approval
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Lupin gets tentative US FDA approval

Agency News

Mumbai, Jun 27: Pharma major Lupin Limited (Lupin) announced that it has received tentative approval for its Mirabegron Extended Release (ER) Tablets from the United States Food and Drug Administration (FDA).

The approval is 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 (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency, a release said.

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). (UNI)