Lupin gets USFDA nod for generic product, Sildenafil

Drug firm Lupin on Thursday said it has received approval from the US health regulator to market Sildenafil for Oral Suspension, used to treat erectile dysfunction and pulmonary arterial hypertension, in the American market.

The company has received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA), Sildenafil for Oral Suspension, 10 mg/mL, Lupin said in a statement.

The Mumbai-based company's product is the generic version of Viatris Specialty LLC's Revatio. The product will be manufactured at Lupin's Goa-based manufacturing facility, it added.

As per IQVIA MAT December 2021 data, Sildenafil for Oral Suspension, 10 mg/mL had estimated annual sales of USD 66 million in the US.