Deponit BE/BA Submissions Supported By FDA Guidances - Schwarz Pharma
Recent FDA guidances on bioequivalence support Schwarz Pharma's argument that it has submitted adequate BE and bioavailability data for its transdermal nitroglycerin product Deponit under the Drug Efficacy Study Implementation program, Schwarz argued in recent correspondence to FDA.
You may also be interested in...
FDA is planning to conduct a two-year evaluation of its recommended replicate design method to determine whether a transition away from average bioequivalence criterion and towards individual and population BE criteria should occur.
FDA should choose a new reference product for nitroglycerin, manufacturers suggested in letters to FDA requesting hearings on the proposed withdrawal of ANDAs for nitroglycerin products.
FDA is providing opportunities for hearings on its proposals to withdraw approval of 25 ANDAs for certain single-entity coronary vasodilator products containing isosorbide dinitrate, and for one NDA and five ANDAs for certain nitroglycerin transdermal systems. The agency is proposing to withdraw approval for the products because the sponsors failed to submit bioequivalency/bioavailability data required under the Drug Efficacy Study Implementation program. Several of the products listed in the March 22 and March 25 Federal Register notices are no longer being marketed, sponsors indicated