Lupin rises after tentative USFDA approval for Mirabegron tablets

Lupin was up 1.83% to Rs 777.45 at 09:46 IST on the BSE after the company said it received tentative US drug regulator's approval for Mirabegron ER tablets.

The announcement was made after market hours yesterday, 27 June 2019.

Meanwhile, the S&P BSE Sensex was down by 51.77 points, or 0.13% to 39,534.64.

On the BSE, 62,000 shares were traded in the counter so far compared with average daily volumes of 67,000 shares in the past two weeks. The stock had hit a high of Rs 789.90 and a low of Rs 768 so far during the day. It hit a 52-week high of Rs 986 on 10 September 2018 and a 52-week low of Rs 697.30 on 19 June 2019.

Lupin announced that it 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), which is a generic version of Myrbetriq extended release tablets, 25 mg and 50 mg, of Astellas Pharma Global Development Inc. (Astellas).

Mirabegron ER tablets are indicated for the treatment of overactive bladder (GAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.

Mirabegron ER tablets had annual sales of approximately $1501.6 million in the US (IMS MAT March 2019).

On a consolidated basis, Lupin's net profit fell 46.6% to Rs 288.54 crore on an 8.7% rise in the net sales to Rs 4325.93 crore in Q4 March 2019 over Q4 March 2018.

Lupin is an innovation led transnational pharmaceutical company developing and delivering a wide range of branded and generic formulations, biosimilar products and active pharmaceutical ingredients (APIs) globally.

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