Treats opioid-induced constipation (OIC). NDA 204760, held by Averitas. Naloxegol Oxalate.
As of Nov 13, 2026, NDA 204760 (Movantik), held by Averitas, was first approved by FDA on Sep 16, 2014, with 7 approved supplements and 0 published complete response letters.
MOVANTIK is indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 16, 2014 | Original applicationNew molecular entity · Standard review | Approved |
| MovantikEQ 12.5MG BASE · tablet;oral | Naloxegol Oxalate | RxReference drug |
| MovantikEQ 25MG BASE · tablet;oral | Naloxegol Oxalate | RxReference drug |
| Apr 13, 2020 | Supplement 9Labeling · Standard review | Approved | |
| May 29, 2019 | Supplement 8Labeling · Standard review | Approved | |
| Feb 28, 2018 | Supplement 7Labeling · Standard review | Approved | |
| Aug 1, 2017 | Supplement 5Labeling · Standard review | Approved | |
| Aug 22, 2016 | Supplement 3Labeling · Standard review | Approved | |
| Aug 22, 2016 | Supplement 2Labeling · Standard review | Approved | |
| Jul 22, 2016 | Supplement 1Labeling · Standard review | Approved | |
| Sep 16, 2014 | Original applicationNew molecular entity · 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
