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FDA Accepts Nuvo's Resubmission For Pennsaid(R)
Date:2/19/2009

-Provides Nuvo with PDUFA date of August 5, 2009-

MISSISSAUGA, ON, Feb. 19 /PRNewswire-FirstCall/ - Nuvo Research Inc. (TSX: NRI), a Canadian drug development company focused on the research and development of drug products delivered to and through the skin using its topical and transdermal drug delivery technologies, today announced that the U.S. Food and Drug Administration (FDA) has accepted Nuvo's resubmission of its application for FDA approval to market Pennsaid in the U.S. as a complete response to the FDA's December 28, 2006 Approvable Letter. The FDA has indicated that it intends to advise Nuvo of its decision regarding Pennsaid approvability by August 5, 2009 (the "PDUFA Date") under the Prescription Drug User Fee Act.

Pennsaid, a topical non-steroidal anti-inflammatory drug (NSAID), is currently marketed in Canada and several European countries to treat the pain and symptoms associated with osteoarthritis.

"We are now less than six months away from the anticipated approval of Pennsaid in the U.S.," said Dr. Henrich Guntermann, President and CEO of Nuvo Research. "We are extremely optimistic about Pennsaid's potential for approval and are continuing discussions with potential U.S. licensing partners."

About Pennsaid

Pennsaid is a topical non-steroidal anti-inflammatory drug used for the treatment of osteoarthritis. Pennsaid allows the active ingredient, diclofenac, to be delivered to a specific site via the surface of the skin and thus limits complications associated with systemic delivery. According to published clinical trials, Pennsaid is as effective as the maximum daily dose of comparable oral medication at relieving pain and stiffness associated with osteoarthritis of the knee, as well as improving overall well-being. There are more than 27 million Americans suffering from osteoarthritis, a very painful and debilitating condition, and the United States market for this condition
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SOURCE Nuvo Research Inc.
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