CIBA-GEIGY's LAMPRENE (CLOFAZIMINE) "APPROVABLE"
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.
More from Archive
Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.
We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.
A new pilot aims to take Brazil closer to ‘digital transformation.’
More from Pink Sheet
In this second of a two-part series of articles, US Pharmacopeia CEO Ronald T. Piervincenzi tells the Pink Sheet which animal testing models have alternative options and highlights where further investment and research is needed to develop appropriate alternatives.
A “basket approach” to phasing out animal testing could help identify areas where “moonshot” research is required to implement new approach methodologies, according to EU industry federation EFPIA.
Vertex said it reached “a broad reimbursement agreement” with the National Health Service for its once-daily, triple combination treatment for cystic fibrosis. As for reimbursement in the rest of Europe, the company is targeting Ireland, Denmark and Germany next.