For partial-onset seizures. ANDA 211821, held by Alembic. Lamotrigine.
As of Nov 14, 2026, ANDA 211821 (Lamotrigine), held by Alembic, was first approved by FDA on Oct 1, 2024, with 0 approved supplements and 0 published complete response letters.
Lamotrigine extended-release tablets are indicated for: adjunctive therapy for primary generalized tonic-clonic seizures (PGTC) and partial-onset seizures with or without secondary generalization in patients aged 13 years and older. conversion to monotherapy in patients aged 13 years and older with partial-onset seizures who are receiving treatment with a single antiepileptic drug (AED). Limitation of use: Safety and effectiveness in patients younger than 13 years have not been established. 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 1, 2024 | Original application | Approved | None posted |
| Lamotrigine200MG · tablet, extended release;oral | Lamotrigine | Rx |
| Lamotrigine250MG · tablet, extended release;oral | Lamotrigine | Rx |
| Lamotrigine300MG · tablet, extended release;oral | Lamotrigine | Rx |
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
