September 22, 2022: Lupin Ltd., one of the top Indian pharmaceutical majors, has received approval from the US drug regulator United States Food and Drug Administration for its Abbreviated New Drug Application, Diclofenac Sodium Topical Solution, according to a statement.
The FDA nod came for its USP, 2% w/w to market a generic equivalent of Pennsaid® Topical Solution, 2% w/w of Horizon Pharma Ireland DAC, a BSE filing stated.
“The product will be manufactured at Lupin’s facility in Pithampur, India.”
The product has an estimated annual sales of $484 million in the US.
Lupin is a company headquartered in India’s financial capital Mumbai. The company develops and commercialises 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 the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.
The company leads in the cardiovascular, anti-diabetic, and respiratory segments. It is significant in the anti-infective, gastrointestinal (GI), central nervous system (CNS), and women’s health areas.
Lupin is the third-largest pharmaceutical company in the US by prescriptions. The company invested 8.7% of its revenue in research and development in the financial year 2022. Lupin has 15 manufacturing sites, seven research centres, and more than 20,000 professionals working globally.
Prescription diclofenac topical solution (Pennsaid) relieves osteoarthritis pain in the knees. Diclofenac is in a class of medications called nonsteroidal anti-inflammatory drugs (NSAIDs). It works by stopping the body’s production of a substance that causes pain.
It is also used to treat mild-to-moderate and helps to relieve symptoms of arthritis (osteoarthritis or rheumatoid arthritis), such as inflammation, swelling, stiffness, and joint pain.
Diclofenac is more potent than Ibuprofen and must be taken twice or three times per day. Ibuprofen often needs to be taken in higher doses to treat pain from arthritis.
The common side effects of Diclofenac are burning, itching, redness, skin rash, swelling, or soreness at the application site.