FDA gives Lupin’s generic Myrbetriq tentative nod

BY Sandra Levy

Lupin has received tentative approval from the Food and Drug Administration for mirabegron extended release tablets, in dosage strengths of 25 mg and 50 mg.

The product is the generic of Astella Pharma’s Myrbetriq extended release tablets, 25 mg and 50 mg, of

It is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.

Mirabegron ER tablets 25 mg and 50 mg had a market value of roughly $1.5 billion, according to March 2019 IQVIA data.


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