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  • Regulatory NewsRegulatory News

    CGT Exclusivity: How the Timing of Commercialization Caused Apotex to Lose its 180 Days

    When Apotex won approval and competitive generic therapy (CGT) exclusivity for its abbreviated new drug application (ANDA) for potassium chloride 10% and 20%, the company thought it would enjoy the 180 days’ worth of exclusivity that comes with the designation, though FDA explains in a letter released Friday why that was not the case. From Apotex’s perspective, the CGT exclusivity should have blocked FDA from approving another ANDA from Novel Laboratories for the same p...