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Panacea Biotec surged 15% to Rs 276, also its 52-week high on the BSE, after the company announced the launch of Prasugrel tablets in US market.
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
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
