Treats mild to moderate plaque psoriasis. NDA 208079, held by Primus Pharms. Betamethasone Dipropionate.
As of Nov 13, 2026, NDA 208079 (Sernivo), held by Primus Pharms, was first approved by FDA on Feb 5, 2016, with 3 approved supplements and 0 published complete response letters.
SERNIVO Spray is indicated for the treatment of mild to moderate plaque psoriasis in patients 18 years of age or older.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 5, 2016 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| SernivoEQ 0.05% BASE/SPRAY · spray;topical | Betamethasone Dipropionate | RxReference drug |
| Sep 26, 2025 | Supplement 4Manufacturing | Approved | |
| Mar 24, 2020 | Supplement 2Labeling · Standard review | Approved | |
| Nov 30, 2018 | Supplement 1Labeling · Standard review | Approved | |
| Feb 5, 2016 | 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
