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FDA's Dermatologic Drugs Advisory Committee

Executive Summary

Agenda for May 6 meeting includes potential safety issues concerning Reed and Carnrick's Rx anti-lice shampoo Kwell (lindane 1%) raised by new epidemiologic data suggesting an association between the shampoo and development of brain tumors in children. There will be closed committee deliberations in the morning with open discussion starting at 1 p.m. On May 7, beginning at 8:30 a.m., the committee will consider new indications for Schering's Elocon (mometasone furoate 0.1%) ointment and cream for use in children; and for pulse dose/maintenance therapy with high-and super-potent topical corticosteroids in treating psoriasis. Elocon is indicated for the relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. The meeting will be held at FDA's Parklawn Building in Conference Rooms D & E.
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