Pharma Major, Panacea Biotec today said it has received final approval from the US health regulator to launch generic Prasugrel tablets, Prasugrel tablets are used for preventing blood clots in people with acute coronary syndrome, in the American market.
''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),'' company said in a filing with BSE. 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 USD600 million in the US market, it added.
The drug indicated for reduction of thrombotic cardiovascular events in people with acute coronary syndrome, after receiving its first-to-file ANDA approval from the United States Food and Drug Administration (USFDA). Under the US law, Panacea Biotech is entitled for 180-days of shared marketing exclusivity for Prasugrel tablets. The company had earlier managed to get the tentative approval for this ANDA. The product has been launched in the market by Apotex Corp., a Canadian-owned pharmaceutical company which is the exclusive sales and distribution partner of Panacea for Prasugrel in the US. The annual sale of Prasugrel prior to the entry of generics in the market was around $600 million in the US.