Teva, Pfizer Seek Clarity on Tentative ANDA Approval Draft Guidance

With the overall goal of reducing the number of complete response letters (CRLs) between tentative approval and final approval for abbreviated new drug applications (ANDAs), Teva Pharmaceuticals and Pfizer are calling on the US Food and Drug Administration (FDA) to elaborate further on some specifics in a draft guidance on tentatively approved ANDAs.