USFDA gives nod to Lupin for Sildenafil for oral suspension

The product will be manufactured at Lupin’s facility in Goa, according to a company statement.

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USFDA Approval
USFDA Approval

Last Updated on October 15, 2024 by The Health Master

Lupin today announced that it 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.

This approval is 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.

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