Alembic Pharmaceuticals has secured 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. (Actelion).

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. Refer label for a detailed indication.

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 Hatch-Waxman Act. Upon final approval of this ANDA by USFDA, Alembic may be eligible for 180 days of generic marketing exclusivity in the US.

Alembic has a cumulative total of 208 ANDA approvals (180 final approvals and 28 tentative approvals) from USFDA.

Alembic Pharmaceuticals Limited, a vertically integrated research and development pharmaceutical company, has been at the forefront of healthcare since 1907. Headquartered in India, Alembic 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.