Glenmark receives USFDA nod for generic Trospium tablets

Drug maker Glenmark Pharmaceuticals today said it has received US health regulator's nod to sell generic trospium tablets, used for treating urinary problems, in the American market.

Glenmark Generics Inc, a US-based subsidiary of the company has got a final approval from the US Food and Drug Administration (US FDA) for marketing and distribution of trospium tablets in 20 mg strength, Glenmark Pharmaceuticals said in a filing to Bombay Stock Exchange (BSE).

Trospium tablets are indicated in the treatment of over-active bladder, a condition that causes a sudden and unstoppable urge to urinate even though the bladder may contain less amount of urine with symptoms of involuntary leakage of urine, urgency and urinary frequency.

These tablets are generic version of Sanctura tablets manufactured by Allergan Inc, a major multi-specialty health care provider.

According to IMS Health, Sanctura tablets have achieved annual sales of $25 million for twelve-month period ended June 30, 2010.

With today's approval, Glenmark's total final approval in the second quarter of this fiscal has gone up to eight along with two tentative approvals.

The company is currently authorised to distribute 61 products in the US and has 45 products pending approval with US FDA.

The company's shares were trading at Rs 269.60 on BSE in the late afternoon trade, up 1.03 per cent from its previous close.