For type 2 diabetes mellitus. NDA 20866, held by Veroscience. Bromocriptine Mesylate.
As of Nov 13, 2026, NDA 20866 (Cycloset), held by Veroscience, was first approved by FDA on May 5, 2009, with 9 approved supplements and 0 published complete response letters.
CYCLOSET is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 5, 2009 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| CyclosetEQ 0.8MG BASE · tablet;oral | Bromocriptine Mesylate | RxReference drug |
| Aug 17, 2020 | Supplement 12Labeling · Standard review | Approved | |
| Apr 3, 2020 | Supplement 13Labeling | Approved | |
| Feb 6, 2017 | Supplement 6Labeling · Standard review | Approved | |
| Feb 6, 2017 | Supplement 7Labeling · Standard review | Approved | |
| Feb 2, 2016 | Supplement 9Labeling · Standard review | Approved | |
| Oct 20, 2015 | Supplement 8Labeling · Standard review | Approved | |
| Jun 12, 2013 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Mar 14, 2013 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Mar 24, 2011 | Supplement 2Labeling | Approved | |
| May 5, 2009 | Original applicationNew dosage form · 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
