Teva Pharmaceuticals USA Responds to FDA Findings on Budeprion XL 300 mg

2008-04-16 23:36:30 -

- Teva Pharmaceuticals USA issues the following statement in response to the "Review of Therapeutic Equivalence Generic Bupropion XL 300 mg and Wellbutrin XL 300 mg" released by FDA on April 16, 2008: -0- As the largest generic drug company in the world, Teva's first priority is to ensure that patients receive products with unquestioned safety and effectiveness. Teva Pharmaceutical Industries Ltd. is committed to making affordable, quality healthcare accessible to patients. We constantly work to ensure that all of our products meet FDA's comprehensive regulations governing the review and approval of generic drugs. Teva commends the actions taken by the FDA, to assure patients that Budeprion is both "bioequivalent and therapeutically equivalent to (interchangeable with) Wellbutrin XL 300 mg." Teva is pleased that after their thorough review of Budeprion, the FDA has released this important information to the public.

Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 20 pharmaceutical companies in the world and is the world's leading generic pharmaceutical company. The Company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients, as well as animal health pharmaceutical products. Over 80 percent of Teva's sales are in North America and Europe.

The full FDA Report can be viewed at: www.fda.gov/cder/drug/infopage/bupropion/TE_review.htm.

Teva Pharmaceuticals USA
Denise Bradley, 215-591-8974
denise.bradley@tevausa.com