Impax Labs today announced that the FDA has granted final
approval of the company’s Abbreviated New Drug Application for its generic
version of Adoxa(R) (doxycyline monohydrate, 150 mg capsules). The company is preparing
for product launch through Global Pharmaceuticals, Impax’s generic division. Adoxa(R)
is a tetracycline antibiotic used to treat bacterial infections. According to
Wolters Kluwer Health, U.S.
sales of Adoxa(R) 150 mg capsules were approximately $25 million in the 12
months ended December 2010.