CIBA-GEIGY's LAMPRENE (CLOFAZIMINE) "APPROVABLE"

Executive Summary

CIBA-GEIGY's LAMPRENE (CLOFAZIMINE) "APPROVABLE" status was made by FDA Oct. 31. Lamprene in 50 mg and 100 mg capsule form will be used to treat Hansen's disease (leprosy). The NDA for Lamprene, an orphan drug, was filed June 28, 1985. According to Ciba-Geigy, the firm already markets Lamprene in India and other third world countries. The Centers for Disease Control reports that the incidence of leprosy in the U.S. has increased steadily in the past 20 years. In 1965, there were 96 new Hansen's disease cases diagnosed, 162 new cases in 1975, 223 in 1980, and 290 new cases reported in 1984. The agency attributes the increased incidence largely to immigration of leprosy victims to the U.S.