Lupin gets tentative USFDA approval for Mirabegron tablet

Lupin Limited (Lupin) on Thursday announced that it has received tentative approval from United States Food and Drug Administration (USFDA) for its Mirabegron Extended Release (ER) Tablets, 25 mg and 50 mg.

Mirabegron Extended Release (ER) Tablets, 25 mg and 50 mg is a generic version of Myrbetriq Extended Release Tablets, 25 mg and 50 mg, of Astellas Pharma Global Development Inc. (Astellas). It is used for the treatment of Overactive Bladder (GAB) for people having symptoms such as urge urinary incontinence, urgency, and urinary frequency.

According to the press release, the tablet has had annual sales of US $1501.6 million in the US.

Lupin Limited is a pharma major engaged in developing and delivering branded and generic formulations. It also further produces biotechnology products and APIs globally. It is also a major player in Cardiovascular, Diabetology, Asthma, Pediatric, CNS, Gl, Anti-Infective and NSAID space.

On Thursday, the stock of the company closed at Rs. 763.50, a decrease by 0.62 per cent or Rs. 4.80 per stock. The 52-week high is Rs. 986 and 52-week low is Rs. 697.30.