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Regulatory News In Brief

This article was originally published in The Gray Sheet

Executive Summary

Contraceptive advisory: Norplant contraceptive recipients can discontinue use of any "backup, non-hormonal method of birth control," developer Wyeth and FDA agree. Wyeth had advised doctors in October 2000 to discontinue implanting the system from lots going into distribution beginning in October 1999, based on concern about lower-than-expected release of the hormone levonorgestrel from the implants. Though the concerns have been resolved, Wyeth will stop selling the six-capsule Norplant system due to limitations in the component supply and therefore recommends women implanted with the devices seek alternative contraceptive methods when their implants expire...
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