Pulmonary arterial hypertension treatment: USFDA gives tentative nod to Alembic Pharma Selexipag for Injection

Vadodara: Alembic Pharmaceuticals Limited has announced that the Company has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Selexipag for Injection, 1,800 mcg/vial.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Uptravi for Injection, 1,800 mcg/vial, of Actelion Pharmaceuticals US, Inc.

Selexipag is a prostacyclin receptor agonist indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) to delay disease progression and reduce the risk of hospitalization for PAH.

Pulmonary arterial hypertension (PAH) is a type of high blood pressure that affects the arteries in the lungs and the right side of the heart. It occurs when the small arteries in the lungs become narrowed, blocked, or destroyed, making it harder for blood to flow through the lungs. This causes increased pressure in the pulmonary arteries, forcing the right side of the heart to work harder to pump blood through the lungs.

Based on the most recent update to the FDA’s online paragraph IV database listings, Alembic is the sole first applicant to have filed its ANDA for Selexipag for Injection, 1,800 mcg/vial, containing a Paragraph IV certification under the provisions of the HatchWaxman Act.

Upon final approval of this ANDA by USFDA, Alembic may be eligible for 180 days of generic marketing exclusivity in the U.S. Alembic has a cumulative total of 208 ANDA approvals (180 final approvals and 28 tentative approvals) from USFDA.

Headquartered in India, Alembic Pharmaceuticals Limited is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world. Alembic's state of the art research and manufacturing facilities are approved by regulatory authorities of many developed countries including the USFDA. Alembic is one of the leaders in branded generics in India. Alembic's brands, marketed through a marketing team of over 5000 are well recognized by doctors and patients. 

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