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Article: Teva Receives Follow-up Approvable Letter from FDA Regarding Agilect(R).
- Article from:
- Business Wire
- Article date:
- August 5, 2005
CopyrightCOPYRIGHT 2005 Business Wire. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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JERUSALEM -- Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA). Last evening, Teva received a letter from the FDA regarding its NDA for Agilect(R). 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.
Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 20 pharmaceutical ...