Regulatory PathRegulatory requirements compared

Active substance

Aripiprazole lauroxil

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

ProductStrengthForm · routeApplicantStatusFirst approved
ARISTADA441MG/1.6ML (275.63MG/ML); 662MG/2.4ML (275.83MG/ML); 882MG/3.2ML (275.63MG/ML); 1064MG/3.9ML (272.82MG/ML)suspension, extended release · intramuscularALKERMES INCPrescription5 Oct 2015
ARISTADA INITIO KIT675MG/2.4ML (281.25MG/ML)suspension, extended release · intramuscularALKERMES INCPrescription29 Jun 2018

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACARISTADA ER 1,064 MG/3.9 ML SYR$993.60013per ML23 Sep 2026
US NADACARISTADA ER 441 MG/1.6 ML SYRN$1007.58949per ML23 Sep 2026
US NADACARISTADA ER 662 MG/2.4 ML SYRN$1006.57422per ML23 Sep 2026
US NADACARISTADA ER 882 MG/3.2 ML SYRN$1004.17967per ML23 Sep 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Safety signals and safety-related labeling changes

All safety entries for aripiprazole lauroxil →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.