DU PONT MERCK's ANTIPARKINSONIAN AGENT SINEMET CR IS "APPROVABLE"
Executive Summary
Du Pont Merck's Sinemet CR received "approvable" status on Nov. 27 (see NDA list below). The company said it expects approval of the new sustained-release formulation of the antiparkinsonian agent (carbidopa 50 mg/levodopa 200 mg tablets) "any day now." The sustained-release formulation has been under development for 10 years and a full NDA was filed in April 1988. Du Pont Merck said it will continue to market the standard formulation of Sinemet since some patients require both formulations for treatment. Chart omitted.