SLI 381

Drug Profile

SLI 381

Alternative Names: Adderall XR; Amfetamine salts (mixed, extended release) - Shire; Amphetamine salts (mixed, extended release) - Shire; d,l-Amphetamine and d-amphetamine salts (extended release) - Shire; d,l-Amphetamine and dextroamphetamine salts (extended release) - Shire; d-Amphetamine and d,l-amphetamine salts (extended release) - Shire; Dexamfetamine and d,l-amfetamine salts (extended release) - Shire; Dextroamphetamine and d,l-amphetamine salts (extended release) - Shire

Latest Information Update: 10 Sep 2017

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At a glance

  • Originator Shire Pharmaceuticals Group
  • Class Amphetamines
  • Mechanism of Action Adrenergic receptor agonists
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Attention-deficit hyperactivity disorder

Most Recent Events

  • 25 Feb 2011 Shire receives Paragraph IV Notice Letter from Watson Laboratories advising of the filing of an Abbreviated NDA for a generic version of all approved strengths of SLI 381
  • 17 Aug 2006 Barr Pharmaceuticals has acquired Adderall® Immediate Release from Shire
  • 26 Aug 2005 Health Canada has reinstated the marketing approval of SLI 381 (Adderall XR) following the review of safety information
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