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COPYRIGHT 2005 International Medical News Group
ROCKVILLE, MD. -- No new safety concerns were raised by a review of adverse events reported during a recent 1-year period in adolescents taking a combination oral contraceptive, according to Jean Wendy Temeck, M.D., of the Food and Drug Administration's division of pediatric drug development.
The FDA's review of adverse events that were reported for Ortho Tri-Cyclen and Ortho Tri-Cyclen Lo, which contain norgestimate and ethinyl estradiol, was conducted between December 2003 and January 2005, the year after the FDA granted marketing exclusivity to the drug.
Exclusivity is granted to a drug when companies perform pediatric studies of the product in exchange for a...
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