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FDA Approves Pennsaid 2% (Diclofenac Topical Solution) for Pain of Knee OA
First twice-daily topical NSAID for this indication (January 17)
The FDA has approved the New Drug Application (NDA) for Pennsaid (diclofenac sodium topical solution) 2% w/w (Pennsaid 2%).
Pennsaid 2% is a follow-on product to the original Pennsaid (diclofenac sodium topical solution) 1.5% w/w (Pennsaid 1.5%), which has been marketed by Mallinckrodt in the U.S. since 2010.
Pennsaid 2% will be the first twice-per-day dosed topical nonsteroidal anti-inflammatory drug (NSAID) available in the U.S. for treatment of the pain of osteoarthritis of the knee.
Source: Nuvo Research Inc.; January 17, 2014.