FDA Approves Extended Five-Year Use of Organon's NEXPLANON Contraceptive Implant

Reuters01-17

FDA Approves Extended Five-Year Use of Organon's NEXPLANON Contraceptive Implant

Organon & Co. announced that the US Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for NEXPLANON® (etonogestrel implant). The approval extends the duration of use for NEXPLANON from three years to up to five years for the prevention of pregnancy in women of reproductive potential. The clinical trial supporting the sNDA included women with a wide range of body mass index $(BMI)$ values, including those with overweight or obesity, and reported no pregnancies or new safety findings during years four and five of use. The FDA approval also introduces a new Risk Evaluation and Mitigation Strategy (REMS) program to certify providers in the proper insertion and removal of the implant.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Organon & Co. published the original content used to generate this news brief via Business Wire (Ref. ID: 20260116204496) on January 17, 2026, and is solely responsible for the information contained therein.

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ID: 20260116204496) on January 17, 2026, and is solely responsible for the information contained therein.</span></i>\n</p>\n</div></body></html>\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"BK4559","symbol_name":"巴菲特持仓","start_time":0,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20260117:nNDL3YlC7:1","article_id":"2604940943","we_media_id":"1032215980","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2604940943","pubTimestamp":1768665476,"columns":[],"sourceInfo":null,"weMediaInfo":{"media_name":"Reuters","introduction":"Reuters.com brings you the latest news from around the world, covering breaking news in markets, business, politics, entertainment and technology","home_visible":1,"id":"1032215980","head_image":"https://community-static.tradeup.com/news/4567337cbdf294b657b1fa87c5488b48"},"summary":"Organon & Co. announced that the US Food and Drug Administration  has approved a supplemental New Drug Application  for NEXPLANON . 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