USDA Approves Alembic Pharma's Generic Seizure Treatment

Thursday, 3 October 2024, 01:47

USDA gives nod to Alembic Pharma's generic formulation to treat seizures. Alembic Pharmaceuticals Limited has obtained final approval from the USFDA for its Lamotrigine Extended-Release Tablets, a key treatment for seizures. This approval marks a significant step in making effective treatments more accessible for patients. The company aims to provide a therapeutic alternative comparable to the existing market leader.
Financialexpress
USDA Approves Alembic Pharma's Generic Seizure Treatment

Overview of Alembic Pharma's New Seizure Treatment

Alembic Pharmaceuticals Limited on Thursday announced 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, available in 200 mg, 250 mg, and 300 mg dosages.

Details of the Approval

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Lamictal XR Extended-Release Tablets by GlaxoSmithKline LLC (GSK). These tablets are indicated for:

  • Adjunctive therapy for primary generalized tonic-clonic seizures
  • 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 who are currently treating partial-onset seizures with a single antiepileptic drug

Market Insights

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


Disclaimer: The information provided on this site is for informational purposes only and is not intended as medical advice. We are not responsible for any actions taken based on the content of this site. Always consult a qualified healthcare provider for medical advice, diagnosis, and treatment. We source our news from reputable sources and provide links to the original articles. We do not endorse or assume responsibility for the accuracy of the information contained in external sources.

This article was prepared using information from open sources in accordance with the principles of Ethical Policy. The editorial team is not responsible for absolute accuracy, as it relies on data from the sources referenced.


Related posts


Newsletter

Subscribe to our newsletter for the latest and most reliable health updates. Stay informed and enhance your wellness knowledge effortlessly.

Subscribe