HAYWARD, Calif. – Impax Laboratories Inc. has gained final approval from the Food and Drug Administration of its abbreviated new drug application (ANDA) for doxycyline monohydrate 150-mg capsules.
Impax said Friday that it's preparing to launch the product through Global Pharmaceuticals, the pharmaceutical maker's generic division.
According to Impax, its medication is the generic version of Adoxa, which is a product of Nycomed US Inc.'s PharmaDerm division.
Adoxa is a tetracycline antibiotic used to treat bacterial infections. Impax reported that according to figures from Wolters Kluwer Health, U.S. sales of Adoxa 150-mg capsules totaled approximately $25 million in the 12 months ended in December.