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Stock impact report

Organon Announces US Food and Drug Administration Approval of Supplemental New Drug Application Extending Duration of Use of NEXPLANON® (etonogestrel implant) 68 mg Radiopaque

Organon & Co. (OGN) 
Company Research Source: Business Wire
JERSEY CITY, N.J.--(BUSINESS WIRE)--Organon (NYSE: OGN), a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day, announced today that the US Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for NEXPLANON® (etonogestrel implant), which is indicated for use by women of reproductive potential to prevent pregnancy. The sNDA extends the duration of use of NEXPLANON for up to five years, an extension of the previous three-year indication. During the clinical trial to assess the contraceptive efficacy and safety of extended use (years 4 and 5), no pregnancies were reported and there were no new safety findings.1 Additionally, the study enrolled women with a range of body mass index (BMI) values (17.2 to 64.3 kg/m2), with 38.1% of them having a BMI =30 kg/m2.“Today marks an important milestone for women seeking a highly effective long-acting reversible contraceptive option, as well as anot Show less Read more
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