Alembic Receives USFDA Tentative Approval for Selexipag Injection to Treat PAH

Alembic Pharmaceuticals Limited (Alembic) announced that it has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Selexipag for Injection, 1,800 mcg/vial. This ANDA is therapeutically equivalent to the reference listed drug product (RLD), Uptravi® for Injection, 1,800 mcg/vial, developed by Actelion Pharmaceuticals US, Inc. Selexipag is a prostacyclin receptor agonist used for treating pulmonary arterial hypertension (PAH, WHO Group I), aiming to delay the progression of the disease and reduce the risk of hospitalization for PAH. Detailed indications can be found on the drug's label.

According to the latest FDA updates to the paragraph IV database, Alembic is the sole first applicant to have filed its ANDA for Selexipag for Injection, 1,800 mcg/vial, with a Paragraph IV certification under the Hatch-Waxman Act. Upon receiving final approval from the USFDA, Alembic may qualify for 180 days of exclusive generic marketing in the U.S.

To date, Alembic has accumulated a total of 208 ANDA approvals from the USFDA, comprising 180 final approvals and 28 tentative approvals.