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.