Manages severe chronic pain. NDA 21060, held by Esteve. Ziconotide Acetate.
As of Nov 14, 2026, NDA 21060 (Prialt), held by Esteve, was first approved by FDA on Dec 28, 2004, with 5 approved supplements and 0 published complete response letters.
PRIALT (ziconotide) solution, intrathecal infusion is indicated for the management of severe chronic pain in adult patients for whom intrathecal therapy is warranted, and who are intolerant of or refractory to other treatment, such as systemic analgesics, adjunctive therapies, or intrathecal morphine.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 28, 2004 | Original applicationNew molecular entity · Priority review | Approved |
| Prialt500MCG/20ML (25MCG/ML) · injectable;intrathecal | Ziconotide Acetate | RxReference drug |
| Prialt100MCG/1ML (100MCG/ML) · injectable;intrathecal | Ziconotide Acetate | RxReference drug |
| Prialt200MCG/2ML (100MCG/ML) · injectable;intrathecal | Ziconotide Acetate | Discontinued |
| Prialt500MCG/5ML (100MCG/ML) · injectable;intrathecal | Ziconotide Acetate | RxReference drug |
| Mar 16, 2023 | Supplement 12Labeling · Standard review | Approved | |
| Dec 19, 2012 | Supplement 10Manufacturing · Priority review | Approved | None posted |
| Sep 1, 2011 | Supplement 6Labeling · Standard review | Approved | |
| Apr 18, 2007 | Supplement 3Labeling · Standard review | Approved | |
| May 26, 2005 | Supplement 1Labeling · Standard review | Approved | |
| Dec 28, 2004 | Original applicationNew molecular entity · Priority 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
