FDA approves labeling supplement for Mylan's Amnesteem (isotretinoin)
Mylan Pharmaceuticals received FDA approval for a labeling update to its generic acne drug Amnesteem on September 15, 2026.
Mylan Pharmaceuticals had one regulatory item this week involving its isotretinoin capsule product.
- A supplemental application (submission number 45) for AMNESTEEM, an oral isotretinoin capsule available in 10MG, 20MG, 30MG, and 40MG strengths under ANDA075945, was approved as a labeling change with standard review priority, with a submission status date of 2026-09-15.1
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