Treats opioid-induced constipation (OIC). NDA 208854, held by Bdsi. Naldemedine Tosylate.
As of Nov 14, 2026, NDA 208854 (Symproic), held by Bdsi, was first approved by FDA on Mar 23, 2017, with 3 approved supplements and 0 published complete response letters.
SYMPROIC 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 |
|---|---|---|---|
| Mar 23, 2017 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| SymproicEQ 0.2MG BASE · tablet;oral | Naldemedine Tosylate | RxReference drug |
| Jul 15, 2025 | Supplement 7Labeling · Standard review | Approved | |
| Jan 24, 2018 | Supplement 2Labeling · Standard review | Approved | |
| Aug 1, 2017 | Supplement 1Labeling · Standard review | Approved | |
| Mar 23, 2017 | 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
