Impax granted FDA approval for generic Adoxa

HAYWARD, Calif. — Impax Labs received regulatory approval from the Food and Drug Administration for its generic version of a bacterial infection treatment.

The drug maker on Friday said it received final approval of its abbreviated new drug application for doxycyline monohydrate capsules in the 150-mg strength. The drug, which is a tetracycline antibiotic used to treat bacterial infections, is a generic version of Adoxa. Adoxa is manufactured by PharmDerm, a Nycomed subsidiary.

Impax said its generic division, Global Pharmaceuticals, will launch the product.

U.S. sales of Adoxa in the 150-mg strength were approximately $25 million in the 12 months ended in December 2010, according to Wolters Kluwer.