Impax' NDA for generic version of Adoxa receives final FDA approval

Impax Laboratories, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted final approval of the Company's Abbreviated New Drug Application for its generic version of Adoxa® (doxycyline monohydrate, 150 mg capsules). The Company is preparing for product launch through Global Pharmaceuticals, Impax's generic division.

Adoxa® is a tetracycline antibiotic used to treat bacterial infections. According to Wolters Kluwer Health, U.S. sales of Adoxa® 150 mg capsules were approximately $25 million in the 12 months ended December 2010.