FDA APPROVES ORGANON'S CONTRACEPTIVE IMPLANT

The FDA has approved Organon's contraceptive implant Implanon, which is effective for up to three years, the agency said July 18.

Implanon (etonogestrel implant) 68 mg is a matchstick-sized contraceptive rod made of a soft medical polymer that is implanted just under the skin of a woman's arm during an office procedure and can be removed any time, Organon said in a statement. The drugmaker explained that the product is designed to release a slow, steady dose of progestin over three years to prevent pregnancy and that, once removed, the patient's fertility rapidly returns.

Health professionals will not be allowed to prescribe or implant the product without the proper training, Organon said. The product will become more widely available in the U.S. during 2007 as healthcare professionals are trained in the insertion and removal procedure.

Scott Monroe, CDER's acting director of reproductive and urologic products, noted during a conference call that the product has been used by approximately 2.5 million women in more than 30 countries since 1998.

Because Implanon consists of only one rod, it will present less of a concern that Norplant, an implantable contraceptive that consisted of six matchstick-sized rods, Monroe said. Manufacturer Wyeth discontinued the product in 2002 after reports that it was not releasing the correct amount of estrogen.

About one-third of the women participating in clinical trials chose to have the contraceptive removed, mainly because of unpredictable menstrual bleeding, Monroe said.