Lupin receives USFDA approval for Diclofenac Sodium Topical Solution

22 Sep 2022 , 06:05 PM

Lupin today announced that it has received approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA), Diclofenac Sodium Topical Solution USP, 2% w/w to market a generic equivalent of Pennsaid? Topical Solution, 2% w/w of Horizon Pharma Ireland DAC. The product will be manufactured at Lupins facility in Pithampur, India. Diclofenac Sodium Topical Solution USP, 2% w/w (RLD Pennsaid?) had estimated annual sales of USD 484 million in the U.S. (IQVIA MAT June 2022).Powered by Capital Market – Live News