New Delhi: Glenmark Pharmaceuticals on Wednesday said Glenmark Generics Inc, its US subsidiary, has received final approval from the US health regulator to market its generic Ursodiol tablets, used for treating cirrhosis, in the American market.
Glenmark Generics Inc has received final approval from the United States Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Ursodiol tablets USP in strengths of 250 mg and 500 mg, Glenmark Pharmaceuticals said in a filing to the Bombay Stock Exchange (BSE).
The company said shipping will commence immediately from its New Jersey facility.
“According to IMS Health, for the twelve-month period ending March 2011, total market sales achieved for Ursodiol tablets were $60 million,” it added.
Ursodiol is a generic version of the Urso 250 mg and Urso Forte tablets developed by Axcan, Glenmark said.
“The company’s current portfolio consists of 70 generic products authorized for distribution in the US market and approximately 40 ANDAs filed with the USFDA pending approval,” it added.
Shares of Glenmark were trading at Rs321.75 apiece in the Wednesday afternoon on the BSE, up 2.55% from their previous close.