NDA 21775, held by Cubist Pharms. Alvimopan.
As of Nov 14, 2026, NDA 21775 (Entereg), held by Cubist Pharms, was first approved by FDA on May 20, 2008, with 11 approved supplements and 0 published complete response letters.
| Oct 18, 2013 | Supplement 10Efficacy (new indication or use) · Standard review | Approved | |
| May 20, 2008 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Entereg12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · capsule;oral | Alvimopan | DiscontinuedReference drug |
| Jun 12, 2023 | Supplement 20REMS | Approved | |
| Nov 17, 2020 | Supplement 18Labeling · Standard review | Approved | |
| Dec 19, 2019 | Supplement 15REMS | Approved | |
| Oct 10, 2019 | Supplement 16Labeling · Standard review | Approved | |
| May 18, 2016 | Supplement 13REMS | Approved | |
| May 29, 2014 | Supplement 12Manufacturing · Standard review | Approved | None posted |
| Oct 18, 2013 | Supplement 10Efficacy (new indication or use) · Standard review | Approved | |
| Oct 21, 2012 | Supplement 8Labeling · Standard review | Approved | |
| Sep 25, 2012 | Supplement 7REMS | Approved | |
| Nov 6, 2009 | Supplement 4Labeling · Standard review | Approved | |
| Feb 5, 2009 | Supplement 1Labeling · Standard review | Approved | |
| May 20, 2008 | 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
