FDA Approved: MIRENA — Supplemental Application (Bayer HealthCare Pharmaceuticals Inc.)

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Summary

FDA approved a supplemental application for Mirena (levonorgestrel) by Bayer HealthCare Pharmaceuticals Inc. under NDA 021225. This action updates the labeling …

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Diseases / indications

• Heavy Menstrual Bleeding

Drugs mentioned

• Mirena (levonorgestrel-releasing intrauterine system)

Snippet

SUPPL AP for MIRENA (LEVONORGESTREL)