Alembic Pharmaceuticals receives USFDA approval for Macitentan Tablets, 10 mg

Alembic Pharmaceuticals announced that it has received final approval from the United States Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Macitentan Tablets, 10 mg.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Opsumit Tablets, 10 mg, of Actelion Pharmaceuticals US, Inc.

Macitentan tablets are an endothelin receptor antagonist (ERA) indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) in adults to reduce the risks of disease progression and hospitalisation for PAH. The company stated that users should refer to the label for a detailed indication.

According to IQVIA, Macitentan Tablets, 10 mg, have an estimated market size of US$ 1,180 million for the twelve months ending June 2025.

Alembic has a cumulative total of 224 ANDA approvals (203 final approvals and 21 tentative approvals) from USFDA.