Treats pseudobulbar affect (PBA). NDA 21879, held by Otsuka America Pharm. Dextromethorphan Hydrobromide; Quinidine Sulfate.
As of Nov 14, 2026, NDA 21879 (Nuedexta), held by Otsuka America Pharm, was first approved by FDA on Oct 29, 2010, with 7 approved supplements and 0 published complete response letters.
NUEDEXTA is indicated for the treatment of pseudobulbar affect (PBA). PBA occurs secondary to a variety of otherwise unrelated neurologic conditions, and is characterized by involuntary, sudden, and frequent episodes of laughing and/or crying. PBA episodes typically occur out of proportion or incongruent to the underlying emotional state. PBA is a specific condition, distinct from other types of emotional lability that may occur in patients with neurological disease or injury.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 29, 2010 | Original applicationNew combination · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Nuedexta20MG;10MG · capsule;oral | Dextromethorphan Hydrobromide; Quinidine Sulfate | RxReference drug |
| Jun 11, 2019 | Supplement 14Labeling · Standard review | Approved | |
| Jan 31, 2019 | Supplement 12Labeling · Standard review | Approved | |
| Apr 21, 2017 | Supplement 8Labeling · Standard review | Approved | None posted |
| Nov 18, 2016 | Supplement 7Manufacturing · Standard review | Approved | |
| Aug 14, 2015 | Supplement 6Manufacturing · Priority review | Approved | None posted |
| Jan 20, 2015 | Supplement 5Labeling · Standard review | Approved | |
| Nov 30, 2012 | Supplement 2Manufacturing · Priority review | Approved | None posted |
| Oct 29, 2010 | Original applicationNew combination · Priority 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
