Global pharma major Lupin Limited on Thursday 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.
According to the company’s statement, the product will be manufactured at Lupin’s 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).
Diclofenac topical solution (Pennsaid) is prescribed to relieve osteoarthritis pain in the knees. Diclofenac is in a class of medications called nonsteroidal anti-inflammatory drugs (NSAIDs). According to experts, it works by stopping the body’s production of a substance that causes pain.