Post USFDA nod, Panacea Biotec set to launch Prasugrel tablets in US market

The New Delhi based Panacea Biotec has received final approval from the US Food and Drug Administration to launch generic Prasugrel tablets in the American market


New Delhi: The US Food and Drug Administration has given its approval to Panacea Biotec for launching generic Prasugrel tablets, used for preventing blood clots in people with 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 has been approved by the US Food and Drug Administration (USFDA),” Panacea Biotec said in a BSE filing. The tablets are 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 to entry of generics in the market was around USD 600 million in the US market, it added.

The tablets are indicated for reduction of thrombotic cardiovascular events in people with acute coronary syndrome.