In Brief: Chartex

Executive Summary

Chartex: Claims to have rights to the clinical data referenced by Wisconsin Pharmacal's May 1993 premarket approval application for the Reality female condom. In a Nov. 13 letter to FDA, Chartex responded to Wisconsin Pharmacal's August request to the agency to withdraw Chartex' premarket approval application for its own female condom ("The Tan Sheet" Aug. 28, p. 18). Wisconsin Pharmacal argued in its petition that it has sole rights to the Family Health International data. The Chartex letter maintained that Wisconsin Pharmacal's 1993 application authorized the company to cross-reference the data...