Akzo Nobel’s pharmaceuticals unit, Organon, says that the US Food and Drug Administration has issued an action letter for its implantable contraceptive, Implanon (etonogestrel), maintaining the product’s “approvable” status.
The agency first issued an approvable letter for the single-rod contraceptive implant that protects against pregnancy for up to three years, back in November last year [[03/11/04f]]. Organon is hoping to meet with the FDA over the next few weeks to address the outstanding issues.
At the time, the firm was aiming to launch the device onto the US market some time in 2005 – it had previously hoped for a 2004 launch. Organon says that it remains confident that it will be able to provide the agency with the appropriate information to advance the review.
Implanon has been available in Europe since 1998, and is also marketed in Latin America, Australia and New Zealand.