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IMPAX Laboratories, Inc. reports that the FDA has issued its report concerning the Therapeutic Equivalence of Generic Bupropion XL 300 mg and Wellbutrin XL 300 mg
HAYWARD, Calif., USA | 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:
www.fda.gov/cder/drug/infopage/bupropion/TE_review.htm
About IMPAX Laboratories, Inc.
IMPAX Laboratories, Inc. is a technology based specialty pharmaceutical company applying its formulation expertise and drug delivery technology to the development of controlled-release and specialty generics in addition to the development of branded products. IMPAX markets its generic products through its Global Pharmaceuticals division and markets its branded products through the IMPAX Pharmaceuticals division. Additionally, where strategically appropriate, IMPAX has developed marketing partnerships to fully leverage its technology platform. IMPAX Laboratories is headquartered in Hayward, California, and has a full range of capabilities in its Hayward and Philadelphia facilities. For more information, please visit the Company's Web site at: www.impaxlabs.com.
SOURCE: IMPAX Laboratories, Inc. |
