IPXL news: FDA Approval...
Impax Laboratories Receives Final FDA Approval for Generic Depakote® Extended-Release 500mg Tablets
* Press Release
* Source: Impax Laboratories, Inc.
* On Wednesday August 5, 2009, 1:00 pm EDT
HAYWARD, Calif.--(BUSINESS WIRE)--Impax Laboratories, Inc. (NASDAQ:IPXL - News) today confirmed that the U.S. Food and Drug Administration (FDA) has granted final approval of the Company’s Abbreviated New Drug Application (ANDA) for generic version of Depakote® (divalproex ER) 500mg Extended-release Tablets. The Company received approval on the 250mg tablets in May 2009. Abbott Laboratories markets Depakote® ER for the treatment of epilepsy and bipolar disorders.
The Company expects to launch both the 250mg and 500mg tablets immediately, through Global Pharmaceuticals, Impax’s generic division.
According to Wolters Kluwer Health, U.S. sales of Depakote® ER 250mg and 500mg tablets were approximately $93 million and $633 million, respectively, for the 12 months ended June 30, 2009.
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.
