FDA accepts application for Banner Pharmacaps' generic cancer drug
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.
Interested in this topic? Sign up for our weekly Retail Health Provider e-newsletter.