Alembic Pharmaceuticals Limited announced today that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Lamotrigine Extended-Release Tablets USP in 200 mg, 250 mg, and 300 mg strengths. These tablets are the therapeutic equivalent to GlaxoSmithKline’s Lamictal XR and are indicated for treating seizures in patients aged 13 and older.
The US market for these tablets is estimated to be worth $163 million, as per IQVIA data for the twelve months ending in June 2024. With this approval, Alembic now has a total of 216 ANDA approvals from the USFDA.
