Treats partial-onset seizures. NDA 21872, held by Ucb Inc. Levetiracetam.
As of Nov 14, 2026, NDA 21872 (Keppra), held by Ucb Inc, was first approved by FDA on Jul 31, 2006, with 18 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 KEPPRA injection is for intravenous use only as an alternative for patients when oral administration is temporarily not feasible 1.1 Partial-Onset Seizures
| Oct 23, 2019 | Supplement 28Efficacy (new indication or use) · Standard review | Approved | |
| Oct 30, 2014 | Supplement 16Efficacy (new indication or use) · Standard review | Approved | |
| May 16, 2008 | Supplement 5Efficacy (new indication or use) · Standard review | Approved | |
| Sep 12, 2007 | Supplement 3Efficacy (new indication or use) | Approved | |
| Jul 31, 2006 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Keppra500MG/5ML (100MG/ML) · injectable;intravenous | Levetiracetam | RxReference drug |
| Mar 12, 2024 | Supplement 35Labeling · Standard review | Approved | |
| Aug 17, 2023 | Supplement 34Labeling · Standard review | Approved | |
| Sep 30, 2020 | Supplement 29Labeling · Standard review | Approved | |
| Oct 23, 2019 | Supplement 28Efficacy (new indication or use) · Standard review | Approved | |
| Oct 24, 2017 | Supplement 24Labeling · Standard review | Approved | |
| Apr 24, 2017 | Supplement 23Labeling · Standard review | Approved | |
| Oct 26, 2016 | Supplement 22Labeling · Standard review | Approved | |
| Apr 6, 2016 | Supplement 21Labeling · Standard review | Approved | |
| Aug 14, 2015 | Supplement 19Manufacturing · Standard review | Approved | None posted |
| Mar 10, 2015 | Supplement 17Labeling · Standard review | Approved | |
| Oct 30, 2014 | Supplement 16Efficacy (new indication or use) · Standard review | Approved | |
| Aug 7, 2014 | Supplement 18Labeling · Standard review | Approved | |
| Mar 7, 2014 | Supplement 15Labeling · Standard review | Approved | |
| Jul 25, 2013 | Supplement 13Labeling · Standard review | Approved | |
| Jul 25, 2013 | Supplement 12Labeling | Approved | |
| May 16, 2008 | Supplement 5Efficacy (new indication or use) · Standard review | Approved | |
| Sep 12, 2007 | Supplement 3Efficacy (new indication or use) | Approved | |
| Sep 12, 2007 | Supplement 2Labeling · Standard review | Approved | |
| Jul 31, 2006 | 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
