Lupin bags USFDA nod for Diclofenac Sodium Topical Solution to treat arthritic knee pain

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.

Read also: Lupin unveils generic Duexis tablets in US

Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products and APIs in over 100 markets in the U.S., India, South Africa and across Asia Pacific (APAC), Latin America (LATAM), Europe and Middle-East regions.

The Company specializes in the cardiovascular, anti-diabetic, and respiratory segments and has significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS) and women's health areas.

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