Lupin receives US FDA approval for Sildenafil for oral suspension

Lupin today announced that it has received approval from the US 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, of Viatris Specialty LLC. The product will be manufactured at Lupin’s facility in Goa, according to a company statement.

Sildenafil for oral suspension, 10 mg/mL (RLD Revatio) had estimated annual sales of $66 million in the US (IQVIA MAT December 2021), the statement added.