Treats partial-onset seizures. NDA 204417, held by Tripoint. Levetiracetam.
As of Nov 14, 2026, NDA 204417 (Elepsia Xr), held by Tripoint, was first approved by FDA on Dec 20, 2018, with 2 approved supplements and 3 published complete response letters.
ELEPSIA XR is indicated as adjunctive therapy for the treatment of partial-onset seizures in patients 12 years of age and older.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 20, 2018 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Mar 22, 2017 | Elepsia XR (levetiracetam)Facility Inspections, Regulatory Information | Approved |
| Sep 23, 2015 | Elepsia XR (levetiracetam)Facility Inspections, Regulatory Information | Approved |
| Mar 29, 2013 | LevetiracetamClinical Pharmacology, Labeling | Approved |
| Elepsia Xr1GM · tablet, extended release;oral | Levetiracetam | DiscontinuedReference drug |
| Elepsia Xr1.5GM · tablet, extended release;oral | Levetiracetam | DiscontinuedReference drug |
| Mar 12, 2024 | Supplement 9Labeling · Standard review | Approved | |
| Dec 17, 2020 | Supplement 4Labeling · Standard review | Approved | |
| Dec 20, 2018 | Original applicationNew formulation or manufacturer · 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
