Skip to main content

Aristada FDA Approval History

FDA Approved: Yes (First approved October 5, 2015)
Brand name: Aristada
Generic name: aripiprazole lauroxil
Dosage form: Injection
Company: Alkermes, Inc.
Treatment for: Schizophrenia

Aristada (aripiprazole lauroxil) is an extended-release injectable atypical antipsychotic with one-month, six-week, and two-month dosing options for the treatment of schizophrenia.

Development timeline for Aristada

Jul  2, 2018Approval FDA Approves Aristada Initio (aripiprazole lauroxil) for the Initiation of Aristada for Schizophrenia
Jun  6, 2017Approval FDA Approves Two-Month Aristada for Treatment of Schizophrenia
Oct  6, 2015Approval FDA Approves Aristada (aripiprazole lauroxil) for Schizophrenia
Aug 21, 2015Alkermes Provides Update on FDA Review of Aristada for the Treatment of Schizophrenia
Jun  9, 2015Aripiprazole Lauroxil Phase 3 Schizophrenia Study Results Published in Journal of Clinical Psychiatry

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.