FDA’s ENG Label Change: What To Know

Implanon (etonogestrel implant) first received FDA approval in 2006, followed by the improved, radiopaque version, Nexplanon, approved by the FDA in 2010, which is now the only contraceptive implant available in the U.S. It was originally FDA approved for a 3-year use duration, although peer reviewed clinical data had demonstrated efficacy through year 5. Now, as of January 2026, the FDA has formally agreed to extend the label for 5-year use. In this episode, we will review the clinical data that prompted the FDA’s decision, based on a multicenter, single-arm, open-label study evaluating contraceptive efficacy and safety during years 4 and 5 of implant use.1. https://www.contemporaryobgyn.net/view/fda-approves-5-year-use-for-etonogestrel-implant-68-mg-contraceptive2. Organon announces US Food and Drug Administration approval of supplemental new drug application extending duration of use of NEXPLANON (etonogestrel implant) 68 mg Radiopaque. Organon. Press release. January 16, 2026. Accessed January 19, 2026. https://www.organon.com/news/organon-announces-us-food-and-drug-administration-approval-of-supplemental-new-drug-application-extending-duration-of-use-of-nexplanon-etonogestrel-implant-68-mg-radiopaque/3. Ali M, Akin A, Bahamondes L, et al. Extended Use Up to 5 Years of the Etonogestrel-Releasing Subdermal Contraceptive Implant: Comparison to Levonorgestrel-Releasing Subdermal Implant. Human Reproduction. 2016. 4. McNicholas C, Swor E, Wan L, Peipert JF. Prolonged Use of the Etonogestrel Implant and Levonorgestrel Intrauterine Device: 2 Years Beyond Food and Drug Administration-Approved Duration. American Journal of Obstetrics and Gynecology. 2017. 5. McNicholas C, Maddipati R, Zhao Q, Swor E, Peipert JF. Use of the Etonogestrel Implant and Levonorgestrel Intrauterine Device Beyond the U.S. Food and Drug Administration-Approved Duration. Obstetrics and Gynecology. 2015.