Treats agitation associated with schizophrenia or bipolar I disorder. NDA 22549, held by Nova Pneuma. Loxapine.
As of Nov 14, 2026, NDA 22549 (Adasuve), held by Nova Pneuma, was first approved by FDA on Dec 21, 2012, with 5 approved supplements and 0 published complete response letters.
ADASUVE is indicated for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 21, 2012 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Adasuve10MG · powder;inhalation | Loxapine | RxReference drug |
| Jan 27, 2022 | Supplement 10Labeling · Standard review | Approved | |
| Oct 27, 2021 | Supplement 9Labeling · Standard review | Approved | |
| Feb 23, 2017 | Supplement 6Labeling | Approved | |
| Sep 28, 2016 | Supplement 5Labeling · Standard review | Approved | |
| Dec 9, 2013 | Supplement 2REMS | Approved | |
| Dec 21, 2012 | Original applicationNew dosage form · 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
