Navigation Links
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 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 www.nuvoresearch.com.

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 www.sedar.com.


'/>"/>
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:
*Name:
*Comment:
*Email:
(Date:2/8/2016)... ... February 08, 2016 , ... Delta Dental of California and its affiliated ... , Gary D. Radine, who recently retired as president and CEO of Delta Dental ... 2015 CEO of the Year , helped lead the effort to raise funds for ...
(Date:2/8/2016)... ... February 08, 2016 , ... ... of organizations. DocuSyst provides a cloud hosted environment for FileHold software that ... integration with various 3rd party applications using the FileHold web services API. DocuSyst ...
(Date:2/8/2016)... ... 08, 2016 , ... TopConsumerReviews.com recently awarded their highest five-star rating to a ... derived from a cluster of melanin when exposed to sunlight. Although most moles are ... lifetime of embarrassment. Historically, mole removal has involved a painful, often expensive ...
(Date:2/8/2016)... ... , ... According to research by the National Association of ... be certified or obtain continuing education. To increase patient awareness of the lack ... campaign to inform dentists and patients about the possible lack of skills and ...
(Date:2/7/2016)... , ... February 07, 2016 , ... ... Facial Plastics, has added Kybella® to his medical and surgical expertise. Technically known ... approved FDA injectable medication used as a non-surgical alternative for reduction of fat ...
Breaking Medicine News(10 mins):
(Date:2/8/2016)... HEIGHTS, Utah , Feb. 8, 2016 /PRNewswire/ ... and distributor of advanced-technology medical devices and rehabilitation ... related markets, congratulates the Denver Broncos, football team ... Kelvyn H. Cullimore Jr. , Chairman and Chief ... of excellence and we look forward to enhancing ...
(Date:2/8/2016)... 2016 --> ... Allied Market Research titled, "World Synthetic Biology ... estimates the world synthetic biology market to be ... technology segment would continue to lead the market ... collectively, held around half of the market share ...
(Date:2/5/2016)... OAKS, Calif. , Feb. 5, 2016 Amgen ... 5 th Annual Global Healthcare Conference at 9:15 a.m. ... York City . David W. Meline , executive ... at the conference. Live audio of the presentation can be ... , under Investors. A replay of the webcast will also ...
Breaking Medicine Technology: