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Implanon Contraceptive Gets FDA OK

by Medindia Content Team on July 22, 2006 at 6:16 PM
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Implanon Contraceptive Gets FDA OK

The US Food and Drug Administration (FDA) gave approval to an implantable contraceptive called Implanon. The matchstick sized contraceptive is implanted beneath a woman's skin in the forearm and prevents pregnancy for three year after which it may be replaced.

Organon USA, manufacturer of Implanon said that the implant would release a low but steady dose of progestin. Implanon has already been sold in 30 countries since 1998 and an estimated 2.5 million women have benefited from using it.

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"Based on clinical trial data and our review of post-marketing data from other countries, Implanon is a highly effective contraceptive that, importantly, does not depend on patient compliance," said Dr. Scott Monroe, acting director of the U.S. Food and Drug Administration's Division of Reproductive and Urologic Products.

Implanon is the first implantable birth-control device available in the United States since 2002 when another implant called Norplant was withdrawn by Wyeth.

Organon said Implanon should be widely available in the US in 2007.

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