Lupin receives USFDA approval for Slidenafil

Global pharma major Lupin Limited (Lupin) today announced that it 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 USD 66 million
in the U.S. (IQVIA MAT December 2021)