Panacea Biotec’s first-to-file ANDA of Prasugrel 5mg and 10mg tablets has been approved by the United States Food & Drug Administration (US FDA). Under the provisions of Hatch-Warman Act, the company is entitled for 180-days of shared marketing exclusivity for Prasugrel HCL tablets with this final FDA approval. The Company earlier got the tentative approval for this ANDA on May 24, 2017.
The product has been launched in the market by Apotex Corp., the largest Canadian-owned pharmaceutical company which is the exclusive sales and distribution partner for this product In USA. Prasugrel is indicated for reduction of thrombotic cardiovascular events (Including stent thrombosis) in people with acute coronary syndrome (ACS) who are to be managed with percutaneous coronary intervention (PCI). The annual state of Prasugrel prior to the entry of generics in the market was approximately $600 million in USA.
Panacea Biotec is a leading biotechnology company with established research, manufacturing and marketing capabilities. It is one of the largest vaccine producers and leading Biotechnology Companies in India.
