HYDERABAD: Hyderabad -based Granules Pharmaceuticals India Ltd, on Monday, announced that the US Food and Drug Administration (US FDA) has approved its new drug – Sildenafil oral suspension 10 mg/mL. The drug is indicated for the treatment of pulmonary arterial hypertension by the World Health Organization (WHO) in adults to improve exercise ability and delay clinical worsening.
An abbreviated new drug application (ANDA) was filed by Granules Pharmaceuticals, a wholly owned foreign subsidiary of the company, for the oral Suspension.
The drug is bioequivalent and therapeutically equivalent to the reference listed drug (RLD) Revatio oral suspension (10mg/ml) by Viatris Specialty LLC. Granules now has a total of 63 ANDA approvals from the US FDA, 61 final approvals and two tentative approvals.
The current annual US market for Sildenafil for oral suspension is approximately $43 million, according to IQVIA/IMS Health.