Irritability Associated with Autism Spectrum Disorder

• FDA approval · 2025-09-02
  FDA Approved: RISPERIDONE — Original Application (Lupin Pharmaceuticals, Inc.)

  FDA approves Lupin Pharmaceuticals' generic risperidone through an Original Application for use in established indications.

• CLINICAL_TRIALS withdrawal · 2024-11-08
  Clinical Trial Update: A Study of JZP541 in Adults With Irritability Associated With Autism Spectrum Disorder [Phase 2]

  Jazz Pharmaceuticals has withdrawn its Phase 2 trial of JZP541 in adults with irritability associated with autism spectrum disorder.

• FDA approval · 2021-02-01
  FDA Approved: ARIPIPRAZOLE — Supplemental Application (Alembic Pharmaceuticals Inc.)

  FDA approved a supplemental application for ARIPIPRAZOLE from Alembic Pharmaceuticals Inc., authorizing a generic aripiprazole product. The …

• FDA approval · 2014-09-26
  FDA Approved: RISPERIDONE — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA approved Torrent Pharmaceuticals Limited's supplemental application for risperidone (generic), enabling the marketed generic version to …

• FDA approval · 2012-04-30
  FDA Approved: RISPERIDONE — Supplemental Application (Amici Pharma, Inc.)

  FDA approved a supplemental application for RISPERIDONE from Amici Pharma, Inc.

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• FDA approval · 2012-01-03
  FDA Approved: RISPERIDONE — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA approved a supplemental application for risperidone from Torrent Pharmaceuticals Limited.