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:6/24/2016)... ... ... Dr. Seema Daulat, a native Texan and University of Texas at Austin ... July 13, 2016. , Dr. Daulat earned her Doctorate of Medicine (MD) at The ... the Agape Clinic serving Dallas’ underprivileged community. , Following medical school, Dr. Daulat completed ...
(Date:6/23/2016)... ... June 23, 2016 , ... An article published June ... link between head and neck cancer in individuals with unhealthy oral hygiene habits. The ... based on whether they had gum disease, brushed their teeth on a daily basis, ...
(Date:6/23/2016)... TX (PRWEB) , ... June 23, 2016 , ... The ... and business clients throughout Jasper County and the surrounding region, is initiating a charity ... charity drive will raise funds earmarked for a scholarship fund that will be presented ...
(Date:6/23/2016)... ... , ... Virginia Beach resident Sean Kelly suffered from depression after a long ... peace and set out to accomplish a personal mission: a solo 50-mile paddle. Kelly ... came across the story of another special operations veteran, Josh Collins, whom Kelly had ...
(Date:6/23/2016)... ... June 23, 2016 , ... ... the 20th International Congress of Parkinson’s Disease and Movement Disorders. This special session ... experts, highlighting the relevance, novelty, and quality of both clinical and basic research ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... 2016  Collagen Matrix, Inc., ("Collagen Matrix") the ... of collagen and mineral based medical devices for ... Bill Messer has joined the company as ... the growing portfolio of oral surgery, neurosurgery, orthopaedic ... joins the Collagen Matrix executive team as an ...
(Date:6/24/2016)... , June 24, 2016 The Academy ... of recommendations that would allow biopharmaceutical companies ... with entities that make formulary and coverage decisions, a ... "value" of new medicines. The recommendations address ... not appear on the drug label, a prohibition that ...
(Date:6/24/2016)... LEXINGTON, Mass. , June 24, 2016   ... specialty pharmaceutical company developing innovative inhaled drugs, announced today ... when Russell Investments reconstituted its comprehensive set ... 2016. "This is an important milestone for ... "It will increase shareholder awareness of our progress in ...
Breaking Medicine Technology: