Vertice Pharma Petitions FDA on Sucralfate Bioequivalence

Vertice Pharma has petitioned FDA to revise and make more stringent bioequivalence requirements outlined in its “Draft Guidance for Sucralfate Oral Suspension.” In the petition, the company asks the agency to “remove the requirement that a generic sucralfate oral suspension formulation must be both qualitatively and quantitatively the same as Carafate, the reference listed drug (RLD), and to add the requirement for comprehensive, validated, and orthogonal in vitro studies that correlate to in vivo properties to demonstrate bioequivalence (BE).” Vertice argues that recommended studies in the guidance are inadequate to ensure that a generic sucralfate oral suspension product is bioequivalent to the reference-listed drug. It also contends that the requirement for “quantitative sameness of the excipients is unnecessary, and the required bioassays are insufficient.”