Alembic Pharma Gets Tentative US FDA Nod For Pulmonary Arterial Hypertension Treatment

Alembic Pharmaceuticals Ltd. announced on Friday that it has received tentative approval from the US Food and Drug Administration for injections to treat pulmonary arterial hypertension.

The company has received approval for its abbreviated new drug application, Selexipag for Injection, 1,800 mcg per vial, according to an exchange filing.

The approved ANDA is therapeutically equivalent to the reference listed drug product, 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 to delay disease progression and reduce the risk of hospitalisation.

Upon final approval of this ANDA by the US FDA, Alembic may be eligible for 180 days of generic marketing exclusivity in the US.

Shares of Alembic Pharmaceuticals closed 1.15% lower at Rs 987.70 per share, as compared to a 0.77% advance in the Sensex.