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FDA label_change · 2026-02-09

FDA Approved: AMNESTEEM — Supplemental Application (Mylan Pharmaceuticals Inc.)

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Summary

The FDA approved a supplemental application for AMNESTEEM (isotretinoin) from Mylan Pharmaceuticals, resulting in a label/labeling change for the product.

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Diseases / indications

Drugs mentioned

  • AMNESTEEM (isotretinoin)

Snippet

SUPPL AP for AMNESTEEM (ISOTRETINOIN)