15Jul 2024
Alembic Gains FDA Tentative Nod for Selexipag Injection

Alembic Gains FDA Tentative Nod for Selexipag Injection

Alembic Pharmaceuticals has secured tentative FDA approval for its Abbreviated New Drug Application (ANDA) for Selexipag Injection, 1,800 mcg/vial. This approval confirms the therapeutic equivalence of Alembic's product to Actelion Pharmaceuticals' Uptravi. Selexipag, a prostacyclin receptor agonist, treats pulmonary arterial hypertension (PAH) by delaying disease progression and reducing hospitalization risks. Alembic, being the first to file this ANDA, might gain 180 days of U.S. generic marketing exclusivity.

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