Last Updated on October 19, 2024 by The Health Master
USFDA approval
Alembic Pharmaceuticals, a leading Indian pharmaceutical company, has achieved a significant milestone with the US Food and Drug Administration (USFDA) granting final USFDA approval for its generic version of Lamotrigine Extended-Release Tablets.
This USFDA approval marks a significant step forward for Alembic in expanding its presence in the US market.
Lamotrigine Extended-Release Tablets: A Versatile Antiepileptic Drug
Lamotrigine Extended-Release Tablets are a vital antiepileptic medication used to treat various seizure types.
They are indicated for:
- Adjunctive Therapy: Treating primary generalized tonic-clonic seizures and partial-onset seizures in patients aged 13 and older.
- Monotherapy: Converting to monotherapy for patients aged 13 and older with partial-onset seizures who are currently on a single antiepileptic drug.
Market Potential and Therapeutic Equivalence
The estimated market size for Lamotrigine Extended-Release Tablets in the US is substantial, reaching $163 million for the twelve months ending June 2024, according to IQVIA.
Alembic’s USFDA approved ANDA is therapeutically equivalent to the brand-name drug, Lamictal XR, manufactured by GlaxoSmithKline (GSK).
This equivalence ensures that Alembic’s generic version offers the same therapeutic benefits as the original product.
Alembic’s Growing Portfolio of USFDA Approved Products
With the latest USFDA approval, Alembic has now secured a cumulative total of 216 ANDA approvals from the USFDA, including 188 final approvals and 28 tentative approvals.
This achievement underscores the company’s commitment to providing high-quality generic medications to patients in the US market.
In conclusion, Alembic Pharmaceuticals’ successful acquisition of USFDA approval for Lamotrigine Extended-Release Tablets represents a significant step forward in expanding its generic drug portfolio.
This USFDA approval not only strengthens the company’s position in the US market but also offers patients a more affordable alternative to the brand-name medication.
As Alembic continues to invest in research and development, it is poised to become a major player in the global pharmaceutical industry.
Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.
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