Alembic Pharmaceuticals Limited announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Macitentan Tablets, 10 mg. The product is therapeutically equivalent to Opsumit® (Macitentan) Tablets, 10 mg, of Actelion Pharmaceuticals US, Inc.
Macitentan is an endothelin receptor antagonist (ERA) indicated for treating pulmonary arterial hypertension (PAH, WHO Group I) in adults, aimed at lowering the risk of disease progression and PAH-related hospitalization.
The approved product has an estimated US market size of around US$ 1,180 million for the twelve months ending June 2025 (IQVIA). With this approval, Alembic now holds a cumulative total of 224 ANDA approvals from the USFDA, including 203 final and 21 tentative approvals.