Azilect
Generic name: rasagiline mesylate
Treatment for: Parkinson's Disease
Teva Receives Follow-up Approvable Letter from FDA Regarding Agilect
JERUSALEM August 5, 2005 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA). Last evening, Teva received a letter from the FDA regarding its NDA for Agilect. While the letter reiterates the FDA's position that the application is approvable, there remain a number of issues that Teva believed it had resolved with its submissions, but as to which the FDA continues to have concerns. The FDA has indicated its interest in a follow-up meeting to discuss issues raised in the letter. Teva intends to meet promptly with the FDA and to work closely with the agency to resolve these issues.
For more information, please visit the Teva Pharmaceutical Industries Ltd. website.
Posted: May 2005
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- FDA Approves Newly Revised Prescribing Information for Azilect Reducing Medication and Food Restrictions - December 14, 2009
- Teva Receives Approvable Letter for Agilect (rasagiline) - July 5, 2004
Azilect (rasagiline mesylate) FDA Approval History
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