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    FDA to Withdraw Generic Drug After Company Repeatedly Fails to Resubmit Bioequivalence Data

    After the US Food and Drug Administration (FDA) discovered an abbreviated new drug application (ANDA) relied on data from a disreputable contract researcher, and after repeated attempts over five years to get the company to resubmit new data, the agency on Friday proposed to withdraw the approval for Cipla subsidiary InvaGen Pharmaceuticals’ trandolapril tablets. “The basis for the proposal is that the holder of the ANDA has repeatedly failed to submit the required data...