Lupin gets approval from USFDA for Sildenafil for oral suspension

24 Mar 2022 Evaluate

Lupin has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA), Sildenafil for Oral Suspension, 10 mg/mL to market a generic equivalent of Revatio for Oral Suspension, 10 mg/mL, of Viatris Specialty LLC. The product will be manufactured at Lupin's facility in Goa, India. Sildenafil for Oral Suspension, 10 mg/mL (RLD Revatio) had estimated annual sales of $66 million in the U.S. (IQVIA MAT December 2021).

Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India.

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