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FDA approval · 2023-10-13

FDA Approved: MYDAYIS — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

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Summary

FDA approved a supplemental application for MYDAYIS (mixed amphetamine salts) from Takeda, updating the drug’s labeling per the supplemental submission.

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Diseases / indications

Drugs mentioned

  • MYDAYIS (mixed amphetamine salts, extended-release)

Snippet

SUPPL AP for MYDAYIS (DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, AND AMPHETAMINE SULFATE)