Granules India gains FDA approval for Sildenafil oral suspension ANDA
Granules India Limited has announced a major achievement with the US Food & Drug Administration (US FDA) approving its Abbreviated New Drug Application (ANDA). The approval was granted to Granules Pharmaceuticals, Inc. (GPI), a wholly-owned foreign subsidiary of Granules India, for their product, Sildenafil for Oral Suspension, 10 mg/mL. This drug is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Revatio for Oral Suspension, 10mg/mL, originally of Viatris Specialty LLC.
Sildenafil for Oral Suspension is specifically indicated for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group I) in adults. It aims to improve exercise ability and delay clinical worsening in patients. With this recent approval, Granules India now boasts a total of 63 ANDA approvals from the US FDA, which includes 61 final approvals and 2 tentative approvals.
According to the latest market data from MAT Sep 2023 by IQVIA/IMS Health, the current annual U.S. market for Sildenafil for Oral Suspension is approximately $43 million. This approval signifies Granules India’s continued commitment to providing effective treatments for complex health conditions and marks a significant step in the pharmaceutical industry’s efforts to enhance patient care in pulmonary arterial hypertension.