Treats seizures associated with Lennox-Gastaut syndrome (LGS). NDA 203993, held by Lundbeck Pharms LLC. Clobazam.
As of Nov 13, 2026, NDA 203993 (Onfi), held by Lundbeck Pharms LLC, was first approved by FDA on Dec 14, 2012, with 9 approved supplements and 0 published complete response letters.
ONFI (clobazam) is indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older. ONFI is a benzodiazepine indicated for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 14, 2012 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Onfi2.5MG/ML · suspension;oral | Clobazam | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 12, 2024 | Supplement 10Labeling · Standard review | Approved | |
| Jan 13, 2023 | Supplement 9Labeling · Standard review | Approved | |
| Feb 5, 2021 | Supplement 8Labeling · Standard review | Approved | |
| Jun 15, 2018 | Supplement 7Labeling · Standard review | Approved | |
| Dec 16, 2016 | Supplement 5Labeling · Standard review | Approved | |
| Jun 16, 2016 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Dec 9, 2014 | Supplement 3Labeling · Standard review | Approved | |
| Jan 16, 2014 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Nov 21, 2013 | Supplement 2Labeling · Standard review | Approved | |
| Dec 14, 2012 | 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
