Title: Bulletin: FDA issues approvable status for single-rod contraceptive implant.

POPLINE Document Number: 281898

Source citation:

Contraceptive Technology Update, 2005 Jan;26(1):[3] p..

Abstract:

American women are one step closer to having a contraceptive implant option with the recent Food and Drug Administration (FDA) issuance of approvable status for Implanon, the single-rod contraceptive implant from Organon (West Orange, NJ). According to the FDA, an approvable letter signals that the agency is prepared to approve the product dependent on the company meeting specified conditions. Organon is in the process of meeting those requests, states Frances DeSena, company spokeswoman. “Our next step is to provide FDA with the information they have requested so that we are can obtain approval,” says DeSena. “Based on that approval, Organon plans to launch sometime in the first half of 2005.” Implanon is inserted under the skin of the upper arm, and provides contraception for up to three years. Consisting of a nonbiodegradable rod measuring 40 mm in length and 2 mm in diameter, the device releases the progestin etonogestrel at an average release rate of 40 mcg per day. Since the device does not contain estrogen, women who do not tolerate or are contraindicated to estrogen use may safely use it. (excerpt)

Keywords:

United States
Contraceptive Implants
Product Approval
USFDA
Information
Use-Effectiveness
North America
Americas
Developed Countries
Contraceptive Methods
Contraception
Family Planning
Legislation
USPHS
Government Agencies
Organizations
Contraceptive Effectiveness