Organon Announces US FDA Has Accepted for Review a Supplemental New Drug Application for MIUDELLA®, a Hormone-Free Intrauterine Device
Organon announced that the U.S. FDA has accepted for review its supplemental New Drug Application for MIUDELLA, a hormone-free intrauterine device. The application seeks to extend the approved duration of use in the U.S. from 3 years to 6 years.
Why it matters — An approved extension of MIUDELLA's use duration would strengthen the product's competitive position and long-term value for Organon's women's health portfolio.