For partial-onset seizures. ANDA 213949, held by Pharmobedient. Lamotrigine.
As of Nov 14, 2026, ANDA 213949 (Lamotrigine), held by Pharmobedient, was first approved by FDA on Dec 8, 2021, with 1 approved supplement and 0 published complete response letters.
1.1 Adjunctive Therapy Lamotrigine Extended-Release Tablets are indicated as adjunctive therapy for primary generalized tonic-clonic (PGTC) seizures and partial-onset seizures with or without secondary generalization in patients aged 13 years and older. 1.2 Monotherapy Lamotrigine Extended-Release Tablets are indicated for conversion to monotherapy in patients aged 13 years and older with partial-onset seizures who are receiving treatment with a single antiepileptic drug (AED). Safety and effectiveness of Lamotrigine Extended-Release Tablets have not been established as initial monotherapy or for simultaneous conversion to monotherapy from 2 or more concomitant AEDs. 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 8, 2021 | Original application | Approved | None posted |
| Lamotrigine25MG · tablet, extended release;oral | Lamotrigine | Rx |
| Lamotrigine50MG · tablet, extended release;oral | Lamotrigine | Rx |
| Lamotrigine100MG · tablet, extended release;oral | Lamotrigine | Rx |
| Lamotrigine200MG · tablet, extended release;oral | Lamotrigine | Rx |
| Lamotrigine250MG · tablet, extended release;oral | Lamotrigine | Rx |
| Lamotrigine300MG · tablet, extended release;oral | Lamotrigine | Rx |
| Jun 5, 2024 | Supplement 1Labeling · Standard review | Approved | None posted |
| Dec 8, 2021 | Original application | Approved | None posted |
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
