Lupin gets tentative USFDA approval for Mirabegron Extended Release Tablets
28th Jun 2019

Lupin has received tentative approval for its Mirabegron Extended Release (ER) Tablets, 25 mg and 50 mg, from the United States Food and Drug Administration (USFDA), to market a generic version of Myrbetriq Extended Release Tablets, 25 mg and 50 mg, of Astellas Pharma Global Development Inc. (Astellas).

The company'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 (GAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.

Lupin is an innovation led transnational pharmaceutical company developing and delivering a wide range of branded & generic formulations, biotechnology products and APIs globally.