
MISSISSAUGA, Ontario, Dec. 29 (UPI) -- Canadian firm Nuvo Research said Friday it has received an approvable letter from FDA on its topical anti-inflammatory Pennsaid.
Nuvo said its product is a non-steroidal, diclofenac sodium solution for the treatment of osteoarthritis of the knee.
Pennsaid would be the first topical NSAID product approved for the U.S. market, the company said.
Nuvo said the solution uses skin-penetrating technology that allows diclofenac to be delivered directly to the knee, which it said minimizes systemic side effects associated with oral therapies.
The company cannot get full FDA approval to market the product until it has satisfied "certain conditions," over which Nuvo said it plans to meet with the agency early in 2007.
Osteoarthritis affects more than 21 million people in the United States, Nuvo said, quoting statistics from the Arthritis Foundation, with a market valued at $4 billion.
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