Lupin today 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, of Viatris Specialty LLC. The product will be manufactured at Lupins 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).
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