Alembic Pharma Gets USFDA Nod for Macitentan Tablets

New Delhi, Aug 19 (PTI) Alembic Pharmaceuticals Ltd on Tuesday said it has received final approval from the US health regulator for its generic version of Macitentan tablets indicated for the treatment of high blood pressure in the lungs.

The approval by the US Food & Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) of Macitentan tablets of strength 10 mg, Alembic said in a statement.


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

Macitentan tablets are indicated for the treatment of pulmonary arterial hypertension (PAH) in adults to reduce the risks of disease progression and hospitalisation for PAH, the company said.

Citing IQVIA data, the company said Macitentan tablets 10 mg, have an estimated market size of USD 1,180 million for 12 months ended June 2025.