Impax Receives Final FDA Approval For Generic Depakote(R) Extended-Release 250mg Tablets

Main Category: Epilepsy
Also Included In: Regulatory Affairs / Drug Approvals;  Bipolar
Article Date: 07 May 2009 - 8:00 PDT

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Impax Laboratories, Inc. (NASDAQ: IPXL) 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) 250mg Extended-release Tablets. The Company also received tentative approval on the 500mg tablets and expects to receive final approval on August 3, 2009, upon expiration of the 180-day exclusivity period. Abbott Laboratories markets Depakote® ER for the treatment of epilepsy and bipolar disorders.

The Company expects to launch both the 250mg and 500mg tablets on August 3, 2009, through Global Pharmaceuticals, Impax's generic division.

According to Wolters Kluwer Health, U.S. sales of Depakote® ER 250mg and 500mg tablets were approximately $115 million and $796 million, respectively, for the 12 months ended March 2009.

Source
Impax Laboratories, Inc.