www.fdanews.com/articles/81398-fda-gives-approvable-letter-to-valeant
FDA GIVES APPROVABLE LETTER TO VALEANT
October 4, 2005
Valeant Pharmaceuticals said recently that it received an approvable letter from the FDA for its Parkinson's disease treatment Zelapar.
Zelapar, a novel and proprietary formulation of selegiline, is an MAO-B inhibitor that addresses the dopamine deficiency, which characterizes Parkinson's disease. Selegiline, the active ingredient in Zelapar, is approved for this indication in a conventional tablet form. The Zelapar tablet dissolves in seconds and is absorbed in the tissues of the mouth. There is no need to swallow or use liquid in conjunction with this dosage.