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.
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