FDA Approves Novartis’ ACT Coartem for Use in U.S.
FDA on Wednesday approved Novartis' artemisinin-based combination therapy Coartem to treat uncomplicated malaria among adults and children in the U.S., Reuters reports. FDA also awarded Novartis a voucher that can be used to grant priority review status to a future drug under a program aimed at encouraging the development of drugs to treat tropical diseases (Richwine, Reuters, 4/8).FDA's approval of Coartem will make the drug available to U.S. residents planning to travel overseas and in the military. The U.S. reports about 1,500 malaria cases annually, primarily among travelers returning from tropical countries (GlobalHealthReporting.org, 1/5). Murray Lumpkin, deputy FDA commissioner of International and Special Programs, said, "It is encouraging to have new treatment available, particularly for children" (United Press International, 4/8). This is part of the Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.
