Organon Announces US FDA Has Accepted for Review a Supplemental New Drug Application for MIUDELLA®, a Hormone-Free Intrauterine Device

Organon said the FDA accepted its supplemental new drug application for MIUDELLA for review. The application seeks to extend the approved use of the hormone-free IUD in the U.S. from 3 years to 6 years, which could improve the product's competitive positioning and commercial value if approved.