Drug firm Panacea Biotec today said it has received final approval from the US health regulator to launch generic Prasugrel tablets, used for preventing blood clots in people with acute coronary syndrome, in the American market.
The company is also entitled to 180 days of shared market exclusivity for the Prasugrel HCL tablets, it added.
“The company’s first-to-file abbreviated new drug application (ANDA) of Prasugrel 5 mg and 10 mg tablets has been approved by the US Food and Drug Administration (USFDA),” Panacea Biotec said in a BSE filing.
The tablets are a generic version of Eli Lilly’s Effient tablets, it added.
Panacea Biotec Joint MD Rajesh Jain said: “Approval and launch of this first to file ANDA product is an important milestone to achieve growth in our US business.”
The product has been launched in the market by Apotex Corp, which is the exclusive sales and distribution partner for this product in US, Panacea Biotec said.
The annual sale of Prasugrel prior tothe entry of generics in the market was around $600 million in the US market, it added.
The tablets are indicated for reduction of thrombotic cardiovascular events in people with acute coronary syndrome.
Shares of Panacea Biotec were trading 6.74 per cent higher at Rs 255 per scrip on BSE in afternoon trade today.