Granules has received U.S. Food and Drug Administration approval for its generic version of Viatris Specialty’s Revatio –pulmonary arterial hypertension (PAH) treatment.

The product, bioequivalent and therapeutically equivalent to Viatris’s Sildenafil for oral suspension, 10 mg/ml is indicated to improve exercise ability and delaying clinical worsening in patients with PAH, Granules said on approval of the ANDA filed by subsidiary Granules Pharmaceuticals Inc.

The current annual U.S. market for Sildenafil for oral suspension is approximately $43 million, the drugmaker said citing MAT Sep 2023 IQVIA/IMS Health numbers. Granules has a total of 63 ANDA approvals from the U.S FDA (61 final and 2 tentative approvals).