Chiron Vitrasert NDA for CMV filed June 30; collaboration with Roche announced.
Executive Summary
CHIRON VITRASERT OPHTHALMIC IMPLANT NDA REFERENCES ROCHE GANCICLOVIR DMF under an agreement with Hoffmann-La Roche announced July 5. "With the inclusion of ganciclovir [drug master file] reference rights from Roche Bioscience, our filing contains all the information necessary for a rapid FDA review," Chiron said. The company filed an NDA for the ganciclovir ophthalmic implant for treatment of cytomegalovirus retinitis on June 30.