Treats schizophrenia. NDA 209830, held by Alkermes Inc. Aripiprazole Lauroxil.
As of Nov 13, 2026, NDA 209830 (Aristada Initio Kit), held by Alkermes Inc, was first approved by FDA on Jun 29, 2018, with 3 approved supplements and 0 published complete response letters.
ARISTADA INITIO, in combination with oral aripiprazole, is indicated for the initiation of ARISTADA when used for the treatment of schizophrenia in adults.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 29, 2018 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Aristada Initio Kit675MG/2.4ML (281.25MG/ML) · suspension, extended release;intramuscular | Aripiprazole Lauroxil | RxReference drug |
| Jan 22, 2025 | Supplement 20Labeling · Standard review | Approved | |
| Mar 30, 2021 | Supplement 9Labeling · Standard review | Approved | |
| Aug 27, 2020 | Supplement 5Labeling · Standard review | Approved | |
| Jun 29, 2018 | Original applicationNew formulation or manufacturer · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
