Teva Agilect "approvable"
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Teva/Eisai's Parkinson's therapy Agilect (rasagiline) is "approvable" at FDA, the firm announces July 5. The NDA, submitted August 8, 2003, covers use of the MAO-B inhibitor as monotherapy in early Parkinson's disease and as adjunct therapy to levodopa in moderate-to-advanced stages of PD. Teva is highlighting once-daily dosing (1Pharmaceutical Approvals Monthly Sept. 1, 2003, In Brief)...