Healthcare Providers, Healthcare Settings, and Participating Pharmacies Can Now Begin Required Training and Certification in Preparation for MIUDELLA’s Launch Later This Year Organon (NYSE: OGN), a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day, today announced the MIUDELLA ® (copper intrauterine system) Risk Evaluation and Mitigation Strategy (REMS) Program is now open for enrollment at www.miudellarems.com . The website enables healthcare providers, healthcare settings, and eligible specialty pharmacies to complete the certification and enrollment activities required to support the dispensing and insertion of MIUDELLA. MIUDELLA is a hormone-free, copper intrauterine device (IUD) indicated for the prevention of pregnancy in females of reproductive potential for up to 3 years. The purpose of the MIUDELLA REMS is to mitigate the risk of complications due to the improper insertion of MIUDELLA by untrained healthcare
https://www.organon.com/news/organon-opens-rems-program-for-miudella-ahead-of-anticipated-commercial-availability/
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No new safety signals identified during additional three years of extended use Organon holds exclusive global licensing rights to MIUDELLA Organon (NYSE: OGN), a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day, today announced that Sebela Women’s Health will present interim results from an ongoing Phase 3 study evaluating MIUDELLA ® , a hormone-free, copper intrauterine device (IUD), through 6 years of use at the 2026 Society of Family Planning (SFP) Annual Meeting, taking place October 17 to 19, 2026, in San Francisco, California. In June 2026, Organon exclusively licensed global rights to MIUDELLA from Sebela Women’s Health. The prospective, single-arm Phase 3 study is being conducted by Sebela Women’s Health at 42 sites in the United States to evaluate the efficacy and safety of MIUDELLA through 6 years of use. The 6-year outcomes were evaluated in 465 of 1397 and 592 of 1601 enrolled participants in the
https://www.organon.com/news/organon-announces-positive-interim-phase-3-study-results-for-miudella-a-hormone-free-intrauterine-device-iud-through-6-years-of-use-to-be-presented-at-the-2026-society-of-family-planning-an/
Sebela’s sNDA Seeks to Extend Approved Duration of Use from 3 to 6 Years Organon (NYSE: OGN), a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day, today announced the US Food and Drug Administration (FDA) has accepted for review Sebela Women’s Health’s supplemental New Drug Application (sNDA) for MIUDELLA ® (copper intrauterine system) for an extended duration of use for up to 6 years with Prescription Drug User Fee Act (PDUFA) action expected in the second quarter of calendar year 2027. In June of 2026, Organon completed its agreement to exclusively license global rights to Sebela’s MIUDELLA. MIUDELLA is a hormone-free, copper intrauterine device (IUD) indicated for the prevention of pregnancy in females of reproductive potential for up to 3 years and is anticipated to be commercially available in late 2026. The MIUDELLA label includes a Risk Evaluation and Mitigation Strategy (REMS), which is open for enrollment at
https://www.organon.com/news/organon-announces-us-fda-has-accepted-for-review-a-supplemental-new-drug-application-for-miudella-a-hormone-free-intrauterine-device/
This transaction strengthens Organon’s contraception portfolio and expands long-acting reversible options for women Organon (NYSE: OGN), a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day, today announced the completion of a global licensing agreement with Sebela Pharmaceuticals, granting Organon exclusive rights to MIUDELLA ®, a hormone-free, copper intrauterine device (IUD). Please see our prior announcement for a summary of the transaction terms . Approved by the US Food and Drug Administration (FDA) on February 24, 2025, MIUDELLA is the first hormone-free copper IUD to be introduced in the US in over 40 years. Indicated for the prevention of pregnancy for up to three years in females of reproductive potential, MIUDELLA is 99% effective. It features a proprietary SLIMSERT TM technology, which consists of a highly flexible frame and a fully preloaded inserter with a small, tapered insertion tube diameter of 3.7mm. 1
https://www.organon.com/news/organon-completes-agreement-to-license-miudella-sebela-pharmaceuticals-hormone-free-intrauterine-device/
Cynthia M. Patton Cynthia M. Patton is currently General Counsel and Corporate Secretary at Tessera Therapeutics, a biotechnology company. Prior to joining Tessera, Ms. Patton served as General Counsel and Secretary at Verily Life Sciences, a healthtech subsidiary of Alphabet Inc., where she oversaw the compliance, privacy, security, legal and governmental affairs functions of the […]
https://www.organon.com/leadership/cynthia-patton/
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the appointment of Deborah H. Telman as General Counsel for Organon & Co., its intended spinoff of its women’s health, legacy brands and biosimilars businesses. In her new role, Deb will act as senior legal advisor to the Board of Directors, Chief Executive Officer and senior management and will be responsible for the company’s worldwide legal affairs, compliance and global environmental health & safety. She will join Organon from Sorrento Therapeutics where she served as Senior Vice President, General Counsel and Corporate Secretary leading the legal, compliance, human resource and quality functions. Deb has spent more than 20 years in senior executive roles at several global companies including Abbott, Johnson Controls and Boeing. She also brings deep experience in mergers and acquisitions, including a major pharmaceutical spinoff with Abbott at the time of its spin from AbbVie. “ Deb’s
https://www.organon.com/news/merck-announces-appointment-of-organon-and-co-general-counsel/
