NDA 22161, held by Astellas. Regadenoson.
As of Nov 13, 2026, NDA 22161 (Lexiscan), held by Astellas, was first approved by FDA on Apr 10, 2008, with 11 approved supplements and 0 published complete response letters.
LEXISCAN (regadenoson) injection is a pharmacologic stress agent indicated for radionuclide myocardial perfusion imaging (MPI) in patients unable to undergo adequate exercise stress.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 17, 2017 | Supplement 13Efficacy (new indication or use) · Standard review | Approved | |
| Apr 10, 2008 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Lexiscan0.4MG/5ML (0.08MG/ML) · solution;intravenous | Regadenoson | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 31, 2018 | Supplement 15Labeling · Standard review | Approved | |
| Jan 17, 2017 | Supplement 13Efficacy (new indication or use) · Standard review | Approved | |
| Sep 19, 2014 | Supplement 12Labeling · Standard review | Approved | |
| Mar 29, 2014 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Jan 9, 2014 | Supplement 11Labeling · Standard review | Approved | |
| Sep 30, 2011 | Supplement 9Labeling | Approved | |
| Sep 23, 2011 | Supplement 6Labeling · Standard review | Approved | |
| Sep 23, 2011 | Supplement 7Labeling | Approved | |
| Sep 23, 2011 | Supplement 8Labeling | Approved | |
| Dec 23, 2009 | Supplement 4Labeling | Approved | |
| Mar 17, 2009 | Supplement 3Labeling · Standard review | Approved | |
| Apr 10, 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
