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the U.S. Food and Drug Administration (FDA) granted final approval of the Company's Abbreviated New Drug Application (ANDA) for a generic version of Wellbutrin(R) XL 150 mg Extended-release Tablets on Wednesday, November 26, 2008
HAYWARD, CA, USA | November 28, 2008 | IMPAX Laboratories, Inc. announced that the U.S. Food and Drug Administration (FDA) granted final approval of the Company's Abbreviated New Drug Application (ANDA) for a generic version of Wellbutrin® XL 150 mg Extended-release Tablets on Wednesday, November 26, 2008. GlaxoSmithKline markets Wellbutrin® XL for the management of depression. IMPAX’s Global Pharmaceuticals division launched the product immediately following approval. According to Wolters Kluwer Health, U.S. sales of Wellbutrin® XL 150 mg tablets were approximately $950 million in the 12 months ended September 2008.
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. |
