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The company said that its first-to-file Abbreviated. New Drug Application (ANDA) of Prasugrel 5mg and 10mg tablets have been approved by the United States Food & Drug Administration (U.S.FDA).
Under the provisions of Hatch-Waxman Act, the Company is entitled for 180-days of shared marketing exclusivity for Prasugrel HCL tablets with this final FDA approval,” Panacea Biotec said in a press release.
The company earlier got the tentative approval for this ANDA on May 24, 2017.
According to an official release, 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 the US.
Panacea Biotec said Prasugrel has annual sales of approximately USD 600 million in the US and is indicated for reduction of thrombotic cardiovascular (including stent thrombosis) events in people with acute coronary syndrome (ACS) who are to be managed with percutaneous coronary intervention (PCI).
At 01:16 PM; the stock was up 14% at Rs 273 on the BSE, as compared to 0.25% rise in the S&P BSE Sensex. The trading volumes on the counter jumped nearly five-fold with a combined 1.04 million shares changed hands on the BSE and NSE so far.