East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Macitentan Tablets, 10 mg. Aurobindo Pharma’s Macitentan Tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), OPSUMIT® Tablets manufactured by Actelion Pharmaceuticals US, Inc.

Macitentan Tablets are indicated for:

• The treatment of pulmonary arterial hypertension (PAH, WHO Group I) to delay disease progression.