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

Apr 16, 2008 - Teva Pharmaceuticals USA issued the following statement in response to the FDA's "Review of Therapeutic Equivalence Generic Bupropion XL 300 mg and Wellbutrin XL 300 mg":


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.