Organon announces U.S. FDA approved sNDA for Nexplanon

Organon (OGN) announced that the US Food and Drug Administration, FDA, has approved a supplemental New Drug Application, sNDA, for Nexplanon, 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. “Today marks an important milestone for women seeking a highly effective long-acting reversible contraceptive option, as well as another advancement in Organon’s women’s health franchise,” said Organon’s Head of Research and Development and Chief Medical Officer, Juan Camilo Arjona Ferreira, MD. “The sNDA approval of an extended duration up to five years, along with data about the use of Nexplanon in women with varying BMIs, including women with overweight or obesity, is a testament to Organon’s commitment to inclusive and comprehensive women’s healthcare.”