Teva Pharmaceutical Industries Limited (TEVA) Receives Follow-Up Approvable Letter From FDA Regarding Agilect(R); Concerns Remain
10/19/2005 5:09:05 PM
JERUSALEM--(BUSINESS WIRE)--Aug. 5, 2005--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 companies and among the largest generic pharmaceutical companies in the world. The Company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients. Close to 90% of Teva's sales are in North America and Europe.