Catalyst Wire Dossier Catalyst Wire Dossier
FDA approval · 2019-09-13

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

View source ↗

Summary

The FDA approved a supplemental application for MYDAYIS submitted by Takeda, resulting in updated labeling for the ADHD medication. The supplement concerns chan…

Upgrade for the full analysis, importance score, and drug timeline.

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)