MGI PHARMA's SALAGEN FOR RADIATION-INDUCED DRY MOUTH IS "APPROVABLE"
Executive Summary
MGI PHARMA's SALAGEN FOR RADIATION-INDUCED DRY MOUTH IS "APPROVABLE" at FDA, the Minneapolis-based company announced Dec. 29. Salagen, the first systemic formulation of pilocarpine, is a treatment for xerostomia, or chronic dry mouth, caused by radiation therapy for head and neck cancers. Xerostomia causes pain, difficulty eating, sleeping and talking, as well as rapid tooth decay. MGI Pharma submitted the NDA for Salagen in February 1992.