Teva received an approvable letter from the FDA regarding Agilect (rasagiline) in July 2004, and has since submitted additional data to the agency which it believed resolved the concerns raised at that time. However, the latest FDA letter to the company has revealed that it still has concerns over the application.
The FDA has indicated its interest in a follow-up meeting to discuss issues raised in the latest letter, and Teva intends to meet promptly with the FDA and to work closely with the agency to resolve these issues.
The drug has already been approved in the European Union under the name Azilect and is co-marketed in that region by Teva and H Lundbeck.