Granules US partner gets ANDA approval for Prasugrel tablets
New Delhi: Drug firm Granules India said US pharma Windlas LLC has received approval from the US health regulator for generic Prasugrel tablets used for preventing blood clots in people with the acute coronary syndrome.
Granules India through its wholly-owned subsidiary, Granules Pharmaceuticals Inc, had acquired the exclusive rights from USpharma Windlas to market and distribute its four products, including Prasugrel in the USA, the company said in a filing to BSE.
Granules Pharmaceuticals Inc plans to launch the product, it added.
"US Food and Drug Administration (USFDA) has approved abbreviated new drug application (ANDA) filed by USpharma Widlas through its subsidiaries...for Prasugrel tablets 5 mg and 10 mg", Granules India said.
The product is the generic version of Eli Lilly and Company's Effient tablets in the same strengths, it added.
Prasugrel is used to prevent blood clots in people with acute coronary syndrome who are undergoing a procedure after a recent heart attack or stroke, and in people with certain disorders of the heart or blood vessels.
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