FDA Approves Organon's SNDA Extending NEXPLANON Use To Five Years With New REMS Program

(RTTNews) - Organon (OGN) announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for NEXPLANON (etonogestrel implant). NEXPLANON is indicated for use by women of reproductive potential to prevent pregnancy. The sNDA extends the duration of use of NEXPLANON from three years to up to five years. In the clinical trial evaluating contraceptive efficacy and safety during extended use (years 4 and 5), no pregnancies were reported and no new safety concerns were identified.

The FDA approval also includes a new Risk Evaluation and Mitigation Strategy (REMS) program in the United States to reduce complications related to improper insertion and removal. This REMS program builds upon Organon's existing Clinical Training Program (CTP) and controlled distribution program, which has been in place since 2006. It introduces proactive measures to certify healthcare providers in the proper insertion and removal of NEXPLANON, further strengthening patient safety and product reliability.

OGN closed Friday's regular trading session at $8.76, gaining $0.06 or 0.69%. In after-hours trading, the stock slipped slightly to $8.70, down $0.06 or 0.68% by 6:57 PM EST.

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