Tentative approval granted to Alembic Pharmaceuticals for pulmonary hypertension treatment by FDA

Alembic Pharmaceuticals Limited has achieved a significant milestone by securing tentative approval from the US Food & Drug Administration (USFDA) for its Selexipag for Injection, 1,800 mcg/vial. This approval, a critical step in the generic drug application process, marks Alembic’s potential entry into the U.S. market with a generic version of Uptravi for Injection, originally by Actelion Pharmaceuticals US, Inc.

Selexipag, a prostacyclin receptor agonist, is primarily indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I), aimed at delaying disease progression and minimizing the risk of hospitalization due to PAH. Patients and healthcare providers are advised to refer to the product labeling for detailed indications and usage guidelines.

Alembic stands out as the sole first filer of an Abbreviated New Drug Application (ANDA) for Selexipag with a Paragraph IV certification, under the Hatch-Waxman Act provisions. This strategic move could grant Alembic an exclusive 180-day marketing period upon final approval.

With a history dating back to 1907, Alembic Pharmaceuticals Limited is an established name in the pharmaceutical sector, renowned for its vertically integrated operations and robust research and development capabilities. The company is based in India and is listed publicly, boasting a comprehensive portfolio of 208 ANDA approvals from the USFDA—180 final approvals and 28 tentative ones.

Alembic’s commitment to quality is underscored by its state-of-the-art research and manufacturing facilities, which meet the rigorous standards of several developed countries’ regulatory authorities, including the USFDA. As a prominent player in the Indian branded generics market, Alembic enjoys a strong presence, supported by a dedicated marketing team of over 5000 professionals. Their brands are well-recognized and trusted by doctors and patients alike across various regions.

The tentative approval of Selexipag represents a pivotal development in the treatment options available for pulmonary arterial hypertension, a condition that requires advanced therapeutic interventions. Alembic’s entry into this segment underscores its strategic focus on expanding its footprint in the global generics market, potentially enhancing its competitive edge and fostering broader access to essential medications.