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

10 May 2010

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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)

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