News: Teva Pharmaceuticals USA Responds to FDA Findings on …
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:
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:
http://www.fda.gov/cder/drug/infopage/bupropion/TE_review.htm.
