Organon Says Application to Extend Miudella IUD Use to Six Years Accepted by FDA for Review

08:42 AM EDT, 09/14/2026 (MT Newswires) -- Organon (OGN) said Monday the US Food and Drug Administration has accepted for review a supplemental new drug application to extend the approved use duration for intrauterine device Miudella to six years from three. The company acquired exclusive global rights to the device from Sebela Women's Health in June, and expects a regulatory decision under the Prescription Drug User Fee Act in Q2 of 2027. Organon said the device, with the current approved duration of up to three years, is slated to become commercially available in late 2026.