Vadodara, India, 12th July 2024 – Alembic Pharmaceuticals Limited, a renowned name in the pharmaceutical industry, has announced a significant milestone in its ongoing efforts to expand its presence in the global market. The company has received tentative approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Selexipag for Injection, 1,800 mcg/vial. This development marks a crucial step forward in Alembic's mission to provide innovative and effective treatments for serious health conditions.
Selexipag is a prostacyclin receptor agonist, specifically indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I). It plays a pivotal role in delaying disease progression and reducing the risk of hospitalization for patients with PAH. The approved ANDA for Selexipag for Injection, 1,800 mcg/vial, is therapeutically equivalent to the reference listed drug product, Uptravi® for Injection, 1,800 mcg/vial, developed by Actelion Pharmaceuticals US, Inc. This equivalence ensures that patients receive the same therapeutic benefits as the branded version of the drug.
Alembic's tentative approval from the USFDA is noteworthy because it positions the company as the sole first applicant to have filed an ANDA for Selexipag for Injection, 1,800 mcg/vial, containing a Paragraph IV certification under the provisions of the Hatch-Waxman Act. This strategic move potentially grants Alembic 180 days of generic marketing exclusivity in the U.S. upon final approval of this ANDA by the USFDA. Such exclusivity can significantly enhance Alembic's market share and revenue in the highly competitive pharmaceutical industry.
Alembic Pharmaceuticals Limited has a rich legacy of over a century, having been at the forefront of healthcare since 1907. The company's vertically integrated research and development capabilities, coupled with its state-of-the-art manufacturing facilities, have consistently received approvals from regulatory authorities in developed countries, including the USFDA. This latest approval adds to Alembic's impressive track record, bringing its cumulative total to 208 ANDA approvals, comprising 180 final approvals and 28 tentative approvals.
Alembic Pharmaceuticals has always been committed to improving global health outcomes. The company's extensive portfolio of generic pharmaceutical products is marketed worldwide, making high-quality and affordable medicines accessible to millions of patients. In India, Alembic is a leader in branded generics, with a marketing team of over 5000 professionals ensuring that its brands are well-recognized by both doctors and patients.
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Uptravi® is a registered trademark of Actelion Pharmaceuticals and/or its affiliates.
The tentative approval of Selexipag for Injection by the USFDA is a testament to Alembic Pharmaceuticals' dedication to innovation and excellence in the pharmaceutical industry. This approval not only underscores the company's capability in developing therapeutically equivalent generics but also highlights its strategic foresight in securing exclusive marketing rights. As Alembic continues to advance its research and development initiatives, it remains steadfast in its mission to enhance the quality of life for patients worldwide.
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