Thursday, April 17, 2008

IMPAX Reports FDA Finding That Budeprion XL 300 mg Is Safe and Effective

April 17, 2008 - IMPAX Laboratories, Inc. (OTC: IPXL) reports that the U.S. Food and Drug Administration (FDA) has issued its report concerning the Therapeutic Equivalence of Generic Bupropion XL 300 mg and Wellbutrin XL 300 mg and found that our generic buproprion extended-release tablets, marketed as Budeprion XL 300 milligram by our partner Teva Pharmaceutical USA, is a safe and effective choice for consumers in treating depression. In addition, it has been shown to meet all requirements for approval, including bioequivalence to the branded drug, Wellbutrin XL(R) 300 milligram.

"We are committed to providing patients with high quality, lower cost alternatives to branded pharmaceutical products. Recent patient concerns about the bioequivalence of our buproprion product to Wellbutrin XL 300 mg can now be put to rest," commented Larry Hsu, Ph.D., president and chief executive officer of IMPAX Laboratories. "IMPAX is pleased that the study confirms the confidence we have had in our product all along."

The full FDA Report can be viewed at:

http://www.fda.gov/cder/drug/infopage/bupropion/TE_review.htm

(Source: www.pharmalive.com)

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