SOMERSET SELEGILINE SUIT v. FDA HEARING SET FOR SEPT. 4; IN VIVO CONFIDENCE INTERVALS MAY DIFFER BETWEEN ELDEPRYL AND GENERICS FROM ENDO, NOVOPHARM, LEDERLE
Executive Summary
Somerset Pharmaceuticals is seeking to a preliminary injunction against FDA relating to the Aug. 2 approvals of three ANDAs for 5 mg tablets of the adjunctive Parkinson's disease treatment selegiline from DuPont Merck's Endo Labs, Novopharm and Lederle.