FDA Extends Duration of Use for NEXPLANON Implant

Organon announced FDA approval of a supplemental New Drug Application (sNDA) extending the labeled duration of use for NEXPLANON® (etonogestrel implant) 68 mg radiopaque from three to five years. In the extension study evaluating years 4–5, no pregnancies were reported and no new safety findings emerged; the study population included participants across a wide BMI range. The action also implements a new Risk Evaluation and Mitigation Strategy (REMS) program in the U.S. to mitigate insertion/removal complications by strengthening provider training and certification. 

Read the full press release here.