Lupin bags USFDA nod for Diclofenac Sodium Topical Solution to treat arthritic knee pain
The product will be manufactured at Lupin's facility in Pithampur, India.;
Mumbai: Global pharma major, Lupin Limited, has announced that the company has received approval from the United States Food and Drug Administration (USFDA) 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.
Diclofenac sodium topical solution 2% is a nonsteroidal anti-inflammatory drug indicated for the treatment of the pain of osteoarthritis of the knee(s).
The product will be manufactured at Lupin's facility in Pithampur, India.
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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).
Medical Dialogues team had earlier announced that Lupin had launched the authorized generic version of Duexis (ibuprofen and famotidine) Tablets, 800 mg/26.6 mg, of Horizon Medicines LLC.
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