Abbott's submits supplemental approval application for Lupron Depot to FDA

ABBOTT PARK, Ill. Abbott is hoping that the Food and Drug Administration will approve one of its drugs as a treatment for advanced prostate cancer.

The Chicago-based drug maker announced Thursday that the FDA accepted its supplemental approval application for Lupron Depot (leuprolide acetate) in the 45-mg strength. The drug, an injectable, works by suppressing production of testosterone for six months. It is currently available in 7.5-mg, 22.5-mg and 30-mg formulations that work for one, three and four months.

“For many patients with advanced prostate cancer, Lupron Depot is an important treatment option because it can help manage the symptoms of their disease,” Abbott VP global pharmaceutical development Eugene Sun said in a statement. “Abbott is seeking approval for a new six-month formulation to provide greater convenience and dosing flexibility to physicians and patients who could benefit form this medication.”

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