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Mydayis Approval History

  • FDA approved: Yes (First approved June 20th, 2017)
  • Brand name: Mydayis
  • Generic name: amphetamine mixed salts
  • Company: Shire US, Inc.
  • Treatment for: Attention Deficit Hyperactivity Disorder (ADHD)

Mydayis (amphetamine mixed salts) is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 13 years and older.

Development History and FDA Approval Process for Mydayis

Jun 21, 2017Approval FDA Approves Mydayis (mixed salts of a single-entity amphetamine product) – A New Once-Daily Option for ADHD
May 21, 2007FDA Issues Approvable Letter for SPD465 (Triple-Bead MixedAmphetamine Salts) for the Treatment of ADHD in Adults
Jul 21, 2006Shire Announces Filing of SPD465 for the Treatment of Adult ADHD

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