New Delhi: Drug firm Panacea Biotec said it has received final approval from the US health regulator to launch generic Prasugrel tablets, used for preventing blood clots in people with the acute coronary syndrome, in the American market.
The company is also entitled for 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 have been approved by the US Food and Drug Administration (USFDA),” Panacea Biotec said in a BSE filing.
The tablets are the 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 the US, Panacea Biotec said.
The annual sale of Prasugrel prior to entry of generics in the market was around USD 600 million in the US market, it added.
The tablets are indicated for the reduction of thrombotic cardiovascular events in people with the acute coronary syndrome.