Treats partial-onset seizures. NDA 21505, held by Ucb Inc. Levetiracetam.
As of Nov 13, 2026, NDA 21505 (Keppra), held by Ucb Inc, was first approved by FDA on Jul 15, 2003, with 28 approved supplements and 0 published complete response letters.
KEPPRA is indicated for the treatment of partial-onset seizures in patients 1 month of age and older KEPPRA is indicated for adjunctive therapy for the treatment of: Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy 1.1 Partial-Onset Seizures
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 23, 2019 | Supplement 42Efficacy (new indication or use) · Standard review | Approved | |
| Dec 16, 2011 | Supplement 19Efficacy (new indication or use) · Priority review | Approved | |
| Mar 19, 2007 | Supplement 13Efficacy (new indication or use) · Standard review | Approved | |
| Aug 15, 2006 | Supplement 9Efficacy (new indication or use) | Approved | |
| Jun 21, 2005 | Supplement 7Efficacy (new indication or use) · Priority review | Approved | |
| Jul 15, 2003 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Keppra100MG/ML · solution;oral | Levetiracetam | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 12, 2024 | Supplement 53Labeling · Standard review | Approved | |
| Aug 31, 2023 | Supplement 52Labeling · Standard review | Approved | |
| Aug 17, 2023 | Supplement 51Labeling · Standard review | Approved | |
| Sep 30, 2020 | Supplement 44Labeling · Standard review | Approved | |
| Oct 23, 2019 | Supplement 42Efficacy (new indication or use) · Standard review | Approved | |
| Oct 24, 2017 | Supplement 40Labeling · Standard review | Approved | |
| Apr 24, 2017 | Supplement 38Labeling · Standard review | Approved | |
| Oct 26, 2016 | Supplement 36Labeling · Standard review | Approved | |
| Mar 10, 2015 | Supplement 33Labeling · Standard review | Approved | |
| Aug 7, 2014 | Supplement 34Labeling · Standard review | Approved | |
| Mar 7, 2014 | Supplement 31Labeling · Standard review | Approved | |
| Sep 13, 2013 | Supplement 32Manufacturing · Standard review | Approved | None posted |
| Jul 25, 2013 | Supplement 30Labeling | Approved | |
| Dec 16, 2011 | Supplement 26Labeling · Standard review | Approved | |
| Dec 16, 2011 | Supplement 25Labeling · Standard review | Approved | |
| Dec 16, 2011 | Supplement 20Labeling · Standard review | Approved | |
| Dec 16, 2011 | Supplement 19Efficacy (new indication or use) · Priority review | Approved | |
| Aug 10, 2011 | Supplement 29REMS | Approved | |
| Apr 23, 2009 | Supplement 24Labeling · Standard review | Approved | |
| Apr 23, 2009 | Supplement 22Labeling · Standard review | Approved | None posted |
| Apr 23, 2009 | Supplement 21Labeling | Approved | |
| Sep 12, 2007 | Supplement 15Labeling · Standard review | Approved | |
| Mar 19, 2007 | Supplement 13Efficacy (new indication or use) · Standard review | Approved | |
| Aug 15, 2006 | Supplement 9Efficacy (new indication or use) | Approved | |
| Jan 24, 2006 | Supplement 6Labeling · Standard review | Approved | |
| Jun 21, 2005 | Supplement 7Efficacy (new indication or use) · Priority review | Approved | |
| Oct 26, 2004 | Supplement 3Labeling · Standard review | Approved | |
| Oct 26, 2004 | Supplement 2Labeling · Standard review | Approved | |
| Jul 15, 2003 | 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
