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.