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.
Read also: Lupin gets Health Canada nod for plaque psoriasis treatment Rymti
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.
Read also: Lupin unveils Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution in US
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.