Alembic receives tentative OK from FDA for generic Uptravi
Selexipag is indicated for the treatment of pulmonary arterial hypertension to delay disease progression and reduce the risk of hospitalization.
Alembic has received tentative approval from the Food and Drug Administration for selexipag for injection, 1,800 mcg per vial, which is the generic of Actelion’s Uptravi.
Selexipag is a prostacyclin receptor agonist indicated for the treatment of pulmonary arterial hypertension to delay disease progression and reduce the risk of hospitalization.
Alembic may be eligible for 180 days of generic marketing exclusivity in the United States, upon approval.