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news.Akzo Nobel unit Organon has said that it will meet with the FDA after the US regulaotr issued an action letter with regard to the company's implantable contraceptive, Implanon.
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Although Implanon has maintained its “approvable” status, Organon will meet with the agency over the next few weeks to discuss any outstanding issues. Organon is said to be confident that it will be able to provide the FDA with the appropriate information to expedite their review.
Implanon is a single-rod contraceptive implant that is inserted under the skin of the upper arm, which, according Organon, provides highly reliable protection against pregnancy for up to three years.
It consists of a non-biodegradable rod measuring 40mm in length and 2mm in diameter. After insertion performed by medical professionals the rod slowly releases a progestogenic hormone, etonogestrel. This is the active metabolite of desogestrel, one of the components of many modern oral contraceptive pills.
The average hormone release rate is 40 microgram per day, enough to ensure effective contraceptive protection. Implanon does not contain estrogen, making it suitable for women who do not tolerate or are contraindicated to estrogens.
In clinical trials involving over 2,300 women, the implant took an average of just 1.1 minutes to be inserted and 2.6 minutes to be removed. No pregnancies occurred during use over approximately 73,000 monthly cycles.