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HIGH POINT, N.C. — The Food and Drug Administration has accepted the first regulatory approval application for a generic version of a cancer drug made by Eisai.
Banner Pharmacaps announced Tuesday that it had filed for regulatory approval of generic bexarotene gelatin capsules in the 75-mg strength, a generic version of Eisai's Targretin, used to treat cutaneous T-cell lymphoma, or CTCL skin cancer. Under the Hatch-Waxman Act of 1984, once the drug is approved, Banner will be the exclusive supplier of a generic version of Targretin for 180 days.
"Knowing that our company is able to have a positive impact on the healthcare costs and treatment for cancer patients in the United States is inspiring and immensely rewarding," Banner president and CEO Roger Gordon said.