Sanofi Plaquenil petition asks FDA to set biostudy guidance; Copley generic is target of state petitions.
Executive Summary
PLAQUENIL BIOSTUDIES REQUIRE "ADEQUATE ASSAY SENSITIVITY," SANOFI WINTHROP maintains in a citizen petition filed with FDA Jan. 20. The firm "requests that FDA adopt bioequivalence testing guidance for hydroxychloroquine that assures adequate assay sensitivity and separation of the major metabolites to demonstrate that these metabolites do not co-elute with the parent compound during chromatographic separation," the petition states. Sanofi, which bought out its joint venture with Sterling Oct. 1, markets the innovator hydroxychloroquine product Plaquenil for rheumatoid arthritis and other indications.