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# Alkermes NDA for Add-on Therapy for Aristada
- URL: https://www.fdaweb.com/alkermes-nda-for-add-on-therapy-for-aristada/
- Published: 2017-11-16T12:00:00.000Z
- Updated: 2026-09-14T23:02:09.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140152

FDA has accepted an Alkermes NDA for aripiprazole lauroxil nanocrystal dispersion (ALNCD) as an add-on therapy with its Aristada (aripiprazole lauroxil) extended-release injectable suspension for treating schizophrenia. The agency has set a 6/30/2018 user fee review target action date for the submission. “If approved, administration of ALNCD in conjunction with a single oral dose of 30 mg aripiprazole will replace the need for three weeks of concomitant oral aripiprazole with the first dose of Aristada,” the company says.