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Teva Agilect "approvable" again

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Teva Parkinson's disease treatment Agilect (rasagiline) receives a second "approvable" letter Aug. 4. "There remain a number of issues that Teva believed it had resolved with its submissions, but [where] FDA continues to have concerns," the sponsor states Aug. 5. The firm plans to meet with the agency "promptly" to address the remaining concerns. Teva responded to a July 2004 approvable letter last November, but the review was extended by three months due to a technical error with the NDA...

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