FDA News Digest January 6, 2003 __________________________________________________________________ Prozac OK'd to Treat Depression, Obsessive-Compulsive Disorder in Children FDA has approved the antidepressant Prozac (fluoxetine) for a new use in treating children and adolescents aged seven to 17 for depression and obsessive-compulsive disorder (OCD). Depression affects up to 25 percent of children and about eight percent of adolescents in the United States. OCD affects about two percent of the population and often begins in adolescence or early childhood. http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01187.html __________________________________________________________________ New Antibody Therapy Adds to Options to Treat Rheumatoid Arthritis FDA has approved Humira (adalimumab) for treating rheumatoid arthritis (RA), an inflammatory disease of the joints that affects more than 2 million Americans. Humira is intended for adult patients with moderately-to-severely active rheumatoid arthritis who have responded inadequately to other RA treatments known as disease-modifying anti-rheumatic drugs. http://www.fda.gov/bbs/topics/ANSWERS/2002/ANS01186.html __________________________________________________________________ FDA Issues Smallpox Vaccine Guidance for Blood Industry FDA has issued guidance for the blood industry regarding proper procedures for qualifying potential blood donors who have been recently inoculated with the smallpox virus or who have received other direct exposure to smallpox vaccines. The FDA recommendations are preventive measures pertaining to non-emergency smallpox vaccination and could be modified in the event of widespread emergency smallpox vaccination. http://www.fda.gov/bbs/topics/ANSWERS/2002/ANS01185.html __________________________________________________________________ FDA Establishes Office to Coordinate Review of Combination Products FDA has formed the Office of Combination Products to help streamline the processing of complex drug-device, drug-biologic, and device-biologic products. Duties of the new office include ensuring that combination products receive an effective premarket review and consistent postmarket regulation. http://www.fda.gov/bbs/topics/NEWS/2002/NEW00862.html __________________________________________________________________ Thanks for subscribing to the FDA News Digest. Our next posting will be January 13. To leave this list at any time, send an e-mail to LISTSERV@LIST.NIH.GOV In the body of the message, write SIGNOFF FDA-NEWSDIGEST-L
