Navigation Links
FDA Accepts Nuvo's Resubmission For Pennsaid(R)

-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 is estimated at US$4 billion annually.

About Nuvo Research Inc.

Nuvo is focused on the research and development of drug products delivered to and through the skin using its topical and transdermal drug delivery technologies. Nuvo's lead product is Pennsaid, a topical non-steroidal anti-inflammatory drug used for the treatment of osteoarthritis. Nuvo intends to leverage its skin-penetrating technologies to create a portfolio of topical and transdermal products targeting a variety of indications.

Nuvo Research Inc. is a publicly traded, Canadian pharmaceutical company headquartered in Mississauga, Ontario, with manufacturing facilities in Varennes, Quebec and Wanzleben, Germany and a research and development Center in San Diego, California. For more information, please visit

These forward-looking statements, by their nature, necessarily involve risks and uncertainties that could cause actual results to differ materially from those contemplated by the forward-looking statements. The Company considers the assumptions on which these forward-looking statements are based to be reasonable at the time they were prepared, but caution that these assumptions regarding future events, many of which are beyond the control of the Company, may ultimately prove to be incorrect. Factors and risks, which could cause actual results to differ materially from current expectations, are discussed in the annual report, as well as in the Company's Annual Information Form for the year ended December 31, 2007. The Company disclaims any intention or obligation to update or revise any forward-looking statements whether a result of new information or future events, except as required by law. For additional information on risks and uncertainties relating to these forward-looking statements, investors should consult the Company's ongoing quarterly filings, annual report and Annual Information Form and other filings found on SEDAR at

SOURCE Nuvo Research Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. ROXRO Announces FDA Accepts for Review NDA for ROX-888 for the Management of Acute Moderate to Severe Pain
2. Andre Konski, M.D., M.B.A., Accepts Radiation Oncology Position at Wayne State University and the Karmanos Cancer Institute
3. FDA Accepts Vanda Pharmaceuticals Iloperidone Resubmission and Sets New Action Date
4. FDA accepts Labopharms response for once-daily tramadol as complete Class 2 response
5. FDA Accepts Gentas NDA Amendment as Complete Response for Genasense(R) Treatment of Chronic Lymphocytic Leukemia
6. Partnering With MyPyramid: NUTRIKIDS Accepts the Challenge to Help Families Step Up to Healthier Living
7. AMEX Accepts Lorus Plan to Meet AMEXs Continued Listing Standards
8. Mike Huckabee Accepts Values Voter Presidential Debate
9. ev3 Inc. Accepts Resignation of Dr. John Simpson
10. Lieutenant Governor Catherine Baker Knoll Accepts Women in Government Presidential Leadership Award
11. FDA Accepts New Drug Application for NEBIDO(R) Submitted by Indevus
Post Your Comments:
(Date:6/24/2016)... ... June 24, 2016 , ... Those who have experienced traumatic events may ... to unhealthy avenues, such as drug or alcohol abuse, as a coping mechanism. To ... for healthy coping following a traumatic event. , Trauma sufferers tend to feel a ...
(Date:6/24/2016)... ... ... a crisis. Her son James, eight, was out of control. Prone to extreme mood shifts ... upset him, he couldn’t control his emotions,” remembers Marcy. “If there was a knife ... and say he was going to kill them. If we were driving on the ...
(Date:6/24/2016)... (PRWEB) , ... June 24, 2016 , ... Global law ... magazine’s 2016 Legal Elite. The attorneys chosen by their peers for this recognition are ... , Seven Greenberg Traurig Shareholders received special honors as members of this year’s Legal ...
(Date:6/24/2016)... Diego, CA (PRWEB) , ... June 24, 2016 , ... ... with the American Cancer Society and the Road To Recovery® program to drive cancer ... to seniors and other adults to ensure the highest quality of life and ongoing ...
(Date:6/24/2016)... Plano, TX (PRWEB) , ... June 24, 2016 , ... ... taking part in Genome magazine’s Code Talker Award, an essay contest in which patients ... for an award to be presented at the 2016 National Society of Genetic Counselors ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... -- Research and Markets has announced the ... (Organic Chemical (Sugar, Petrochemical, Glycerin), Inorganic Chemical), Functionality (Filler, ... Global Forecast to 2021" report to their offering. ... pharmaceutical excipients market is projected to reach USD 8.1 ... the forecast period 2016 to 2021. ...
(Date:6/23/2016)... 2016 Research and Markets has announced ... report to their offering. ... a favourable commercial environment for MedImmune to enter. The US ... will serve to drive considerable growth for effective anti-influenza medications. ... cap sales considerably, but development is still in its infancy. ...
(Date:6/23/2016)... June 23, 2016 Revolutionary technology ... Oticon , industry leaders in advanced audiology and ... Oticon Opn ™, the world,s first internet connected ... for IoT devices.      (Photo: ... a number of ,world firsts,: , TwinLink™ ...
Breaking Medicine Technology: