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FDA Issues Approvable Letter for Rasagiline Mesylate
Israel Makov, President and CEO of Teva commented, “We are very pleased to receive this approvable letter, which is a major regulatory milestone in the approval process of AGILECT®". Mr. Makov added, “Today represents another important step towards Teva being able to offer a new treatment option to the many patients who currently suffer from Parkinson's disease in the United States.”
Teva Neuroscience, Inc. and Eisai Inc. will co-promote AGILECT® in the United States once approved by the FDA and Teva and H. Lundbeck A/S will co-promote the product in Europe, once approved there.
Source: Teva Pharmaceutical Industries Ltd.