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Impax anti-bacterial generic drug receives final FDA approval

Impax Laboratories, a California-based specialty pharmaceutical company developing specialty generics and branded products, has received the final approval for the abbreviated new drug application for its generic version of Adoxa (doxycyline monohydrate, 150 mg capsules) from the US Food and Drug Administration (FDA).

Preparations are now underway to launch the product through Global Pharmaceuticals, Impax’s generic division.

Adoxa is a tetracycline antibiotic indicated for the treatment of bacterial infections. According to Wolters Kluwer Health, publishers of medical, nursing and allied health information resources, the US sales of Adoxa 150 mg capsules were about $25 million in the year ended December 2010.

Impax also has facilities in Hayward, Philadelphia and Taiwan.