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FDA Approves Implanon (etonogestrel implant) for Contraception

Arnhem, The Netherlands - July 18, 2006 -- Following its approval by the U.S. Food and Drug Administration, women in the United States now have the option of using the Implanon™ contraceptive implant developed by Akzo Nobel’s human healthcare business, Organon.

About the size of a matchstick, Implanon (etonogestrel implant) 68 mg, is the world’s first and only single-rod implantable contraceptive, and is effective for up to three years. Launched in 1998, it has been used by more than 2.5 million women worldwide and is available in over 30 countries.

“Implanon is a state-of-the-art contraceptive which further demonstrates Organon’s ongoing commitment to continue its leadership position in gynecology,” said Toon Wilderbeek, Akzo Nobel’s Board member responsible for Pharma. “We are excited about the FDA’s approval for Implanon, which represents a real advance in contraceptive technology and will provide women with a new level of confidence in contraception.”

Made of a soft medical polymer, Implanon is inserted just under the skin of a woman’s upper inner arm by a healthcare professional during a simple in-office procedure, after which it is generally not visible. The product continuously releases a low, steady dose of progestogen (etonogestrel) for a period of three years. Removal can occur at anytime at the request of the user, after which the woman’s fertility rapidly returns to pre-existing fertility, commensurate with age. Implanon must be removed at the end of the third year and may be replaced by a new Implanon at the time of removal if continued contraceptive protection is desired.

Organon USA will be conducting a national clinical training program to train healthcare providers on the insertion and removal procedures. Only healthcare professionals trained through the Organon sponsored programs will be able to prescribe Implanon for their patients. The clinical training program is scheduled to begin later this year and, as the training program progresses, Implanon will become more widely available during the course of 2007.

Organon—with shared head offices in Roseland, NJ, USA and Oss, The Netherlands—creates, manufactures and markets innovative prescription medicines that improve the health and quality of human life. Through a combination of independent growth and business partnerships, Organon strives to remain or become one of the leading biopharmaceutical companies in each of its core therapeutic fields: fertility, gynecology, anesthesia and neuroscience. Research areas also include immunology and oncology. Organon products are sold in over 100 countries, of which more than 60 have an Organon subsidiary. Organon—which employs 14,100 people and had revenues of EUR 2,425 million in 2005—is the human healthcare business unit of Akzo Nobel.

Source: Organon

Posted: July 2006

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