Azilect
rasagiline mesylate
Treatment for Parkinson's DiseaseTeva 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.
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Teva Receives Approvable Letter for Agilect (rasagiline) - July 5, 2004
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