Glenmark's US subsidiary gets US FDA approval for Tarka generic

Glenmark's US subsidiary Glenmark Generics Inc has received US FDA's approval to market the generic equivalent of Abbott's Tarka generic. On 22 January it had received a tentative approval from the US drug regulator.

Tarka is used in the treatment of hypertension.

Glenmark has signed a spate of agreements over the past few weeks - Taro Pharmaceuticals, Par Pharmaceuticals, and Sanofi-Aventis.

Last week the company signed an exclusive license and supply agreement for a branded product with Taro Pharmaceuticals USA, Inc, a subsidiary of Israel-based Taro Pharmaceutical Industries Ltd. (See: Glenmark Generics licenses branded drug to Taro USA)

Glenmark Generics will manufacture the FDA-approved product exclusively for Taro Pharmaceuticals USA and will receive milestone payments and a royalty on sales. The market size of the product in the US is $60 million in the next two years.

Earlier last week, Glenmark Generics and Par Pharmaceutical entered into an exclusive licensing agreement for marketing the generic version of Merck & Co's `Zetia', on 4 May.

Under the terms of the agreement, the US specialty pharmaceutical company has made a payment to Glenmark for exclusive rights to market, sell and distribute ezetimibe 10 mg tablets, the generic version of Zetia in the US.

Last week, Glenmark's wholly-owned subsidiary, Glenmark Pharmaceuticals SA entered into an agreement with Sanofi-Aventis for the development and commercialisation of novel agents to treat chronic pain.(See: Glenmark in $325-million drug deal with Sanofi-Aventis)