Alembic Pharmaceuticals gets USFDA’s final approval for Lamotrigine Extended-Release Tablets

03 Oct 2024 Evaluate

Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Lamotrigine Extended-Release Tablets USP, 200 mg, 250 mg, and 300 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Lamictal XR Extended-Release Tablets, 200 mg, 250 mg, and 300 mg, of GlaxoSmithKline LLC (GSK). 

Lamotrigine extended-release tablets are indicated for adjunctive therapy for primary generalized tonic-clonic seizures and partial-onset seizures with or without secondary generalization in patients aged 13 years and older. Also 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. Refer label for a detailed indication.

Lamotrigine Extended-Release Tablets USP, 200 mg, 250 mg, and 300 mg have an estimated market size of $ 163 million for twelve months ending June 2024 according to IQVIA. Alembic has a cumulative total of 216 ANDA approvals (188 final approvals and 28 tentative approvals) from USFDA. 

Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.


Alembic Pharma Share Price

852.30 -4.95 (-0.58%)
26-Dec-2025 16:59 View Price Chart
Peers
Company Name CMP
Sun Pharma Inds. 1719.20
Dr. Reddys Lab 1269.05
Cipla 1505.05
Zydus Lifesciences 911.50
Lupin 2112.95
View more..
Register Now to get our Free Newsletter & much more!

© 2025 The Alchemists Ark Pvt. Ltd. All rights reserved. MoneyWorks4Me ® is a registered trademark of The Alchemists Ark Pvt. Ltd.

×