Treats clinically important hypotension occurring in the setting of anesthesia. NDA 208289, held by Exela Pharma. Ephedrine Sulfate.
As of Nov 13, 2026, NDA 208289 (Akovaz), held by Exela Pharma, was first approved by FDA on Apr 29, 2016, with 3 approved supplements and 0 published complete response letters.
AKOVAZ (ephedrine sulfate injection) is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 29, 2016 | Original applicationTYPE 7 · Standard review | Approved |
| Akovaz50MG/ML (50MG/ML) · solution;intravenous | Ephedrine Sulfate | RxReference drug |
| Akovaz25MG/5ML (5MG/ML) · solution;intravenous | Ephedrine Sulfate | RxReference drug |
| Aug 2, 2021 | Supplement 6Manufacturing · Standard review | Approved | |
| Apr 8, 2020 | Supplement 5Labeling · Standard review | Approved | |
| Aug 10, 2018 | Supplement 2Labeling · Standard review | Approved | |
| Apr 29, 2016 | Original applicationTYPE 7 · 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
