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FDA Expands Approval of Mirena IUD Device | 2022-08-25
- https://www.fdanews.com/articles/209140-fda-expands-approval-of-mirena-iud-device
- August 25, 2022. The FDA has expanded its approval of Bayer’s intrauterine device (IUD) Mirena, extending its use by an additional year to prevent pregnancy. The device was previously approved for up to seven years. The long-acting …
NDA Multi-Disciplinary Review and Evaluation (Mirena)
- https://www.fda.gov/media/152355/download
- Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine (ORPURM) Review Completion Date 10, 2021 Established/Proper Name -releasing …
Drug Approval Package: Mirena (Levonorgestrel …
- https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-225_Mirena.cfm
- Drug Approval Package FDA Home Drugs Drug Approvals and Databases Drugs@FDA Mirena (Levonorgestrel-Releasing Intrauterine System) Company: Berlex …
FDA expands approval of Mirena for up to 8 years
- https://www.contemporaryobgyn.net/view/fda-expands-approval-of-mirena-for-up-to-8-years
- The US Food and Drug Administration (FDA) has approved a supplemental New Drug Application for an extension of Mirena (levonorgestrel-releasing intrauterine …
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