For neurologic conditions associated with problem drooling. NDA 22571, held by Merz Pharms. Glycopyrrolate.
As of Nov 14, 2026, NDA 22571 (Cuvposa), held by Merz Pharms, was first approved by FDA on Jul 28, 2010, with 6 approved supplements and 0 published complete response letters.
CUVPOSA is indicated to reduce chronic severe drooling in patients aged 3 to 16 years with neurologic conditions associated with problem drooling (e.g., cerebral palsy).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 28, 2010 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Cuvposa1MG/5ML · solution;oral | Glycopyrrolate | RxReference drug |
| Feb 23, 2018 | Supplement 8Labeling · Standard review | Approved | |
| May 18, 2016 | Supplement 6Labeling · Standard review | Approved | |
| Feb 8, 2016 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Nov 6, 2015 | Supplement 4Labeling · Standard review | Approved | |
| May 21, 2013 | Supplement 3Labeling · Standard review | Approved | |
| Nov 8, 2012 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Jul 28, 2010 | 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
