Global pharma major Lupin Limited (Lupin) announced that it has received approval from the United States Food and Drug Administration (FDA) 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. Revatio® is a registered trademark 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).
