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The US FDA has accepted the sNDA of Miudella (hormone-free copper intrauterine system) for an extended duration of use for up to 6yrs. with the PDUFA action date expected in Q2’27
Miudella was evaluated in 3 trials across US in 1904 women (17-45yrs.), where the efficacy cohort (17-35yrs.) of the P-III trial (n=1397) showed 99% effectiveness, with a 1yr. Pearl Index of 0.94 & a cumulative 3yr. Pearl Index of 1.05, plus ~99% placement success rate
In Jun 2026, Sebela granted Organon exclusive global rights to Miudella, which was previously approved by the FDA for the prevention of pregnancy in females of reproductive potential for ~3yrs. & is expected to be commercially available in late 2026
Ref: Businesswire | Image: Organon | Press Release
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The post Organon Reports the US FDA sNDA Acceptance for Miudella appeared first on PharmaShots.
