Organon says FDA accepts Miudella IUD sNDA for 6-year use review - OGN News | RalliesOrganon says FDA accepts Miudella IUD sNDA for 6-year use review
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OGN• FDA accepts Organon’s sNDA for Miudella
- The FDA accepted for review a supplemental New Drug Application seeking to extend MIUDELLA copper IUD use to 6 years.
- The PDUFA action date is expected in Q2 2027.
- Organon licensed global rights from Sebela Women’s Health in June 2026; a U.S. commercial launch is expected in late 2026.
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