Alembic Pharmaceuticals announces USFDA Tentative Approval for Selexipag for Injection, 1,800 mcg/vial

~ Alembic is the sole first applicant to file an ANDA for Selexipag for Injection, 1,800 mcg/vial~

15th July 2024, Bengaluru: Alembic Pharmaceuticals Limited (Alembic) today announced that it 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. (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 U.S.

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