FDA Approves Pennsaid
FDA Approves Pennsaid Topical Solution
ST. LOUIS & MISSISSAUGA, Ontario--(BUSINESS WIRE)--Nov 5, 2009 - Covidien, a leading global provider of healthcare products, and Nuvo Research Inc., a Canadian drug development company, today announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application for Pennsaid Topical Solution (diclofenac sodium topical solution) 1.5% w/w.
Pennsaid Topical Solution is a non-steroidal anti-inflammatory drug (NSAID) used for the treatment of the signs and symptoms of osteoarthritis of the knee.
Nuvo develops drug products delivered to and through the skin using its topical and transdermal drug delivery technologies. Covidien is the largest supplier of controlled pain medications in the United States based on number of prescriptions.
"FDA approval of Pennsaid is the most significant milestone in Nuvo's history," said Dan Chicoine, Chairman of Nuvo Research. "We are thrilled that we have been able to successfully navigate a very challenging regulatory pathway for this product and look forward to the upcoming launch of Pennsaid in the U.S. by Covidien. This will support the development of our product pipeline as we progress toward becoming the global leader in the research and development of drug products delivered to or through the skin."
"Building on more than a century of pain treatment experience, Covidien is focused on expanding the limits of pain therapy by combining proven drugs with innovative delivery systems," said Timothy R. Wright, President, Pharmaceuticals, Covidien. "We are pleased to be collaborating with Nuvo Research on this opportunity to expand our branded pharmaceutical portfolio by selling and marketing Pennsaid throughout the United States."
In June, the companies announced that Mallinckrodt Inc., a Covidien company, had entered into a license and development agreement with Nuvo that encompasses Pennsaid Topical Solution and its follow-on topical diclofenac formulation, Pennsaid Plus Gel, which is currently under development. Under the agreement, Covidien is responsible for all U.S. commercialization activities, including marketing, selling and medical education and is responsible for the clinical development of Pennsaid Plus. Nuvo owns and maintains the intellectual property rights to the products and also will be responsible for manufacturing.
The launch of Pennsaid Topical Solution, which Covidien anticipates in the first half of calendar 2010, will include a NSAID medication guide for prescribers, pharmacists and patients.
Covidien is a leading global healthcare products company that creates innovative medical solutions for better patient outcomes and delivers value through clinical leadership and excellence. Covidien manufactures, distributes and services a diverse range of industry-leading product lines in three segments: Medical Devices, Pharmaceuticals and Medical Supplies. With 2008 revenue of $10 billion, Covidien has more than 41,000 employees worldwide in 59 countries, and its products are sold in over 140 countries.
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 and on the development of its immune modulation drug candidate, WF10. Nuvo's lead product is Pennsaid, a topical non-steroidal anti-inflammatory drug (NSAID). Nuvo intends to leverage its skin-penetrating technologies to create a portfolio of topical and transdermal products targeting a variety of indications. Nuvo is a publicly traded, Canadian pharmaceutical company headquartered in Mississauga, Ontario, with manufacturing facilities in Varennes, Québec and Wanzleben, Germany and a research and development Center in San Diego, California.
Any statements contained in this communication that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements contained herein are based on our management's current beliefs and expectations, but are subject to a number of risks, uncertainties and changes in circumstances, which may cause actual results or Company actions to differ materially from what is expressed or implied by these statements. The factors that could cause actual future results to differ materially from current expectations include, but are not limited to, our ability to effectively introduce and market new products or keep pace with advances in technology, the reimbursement practices of a small number of large public and private insurers, cost-containment efforts of customers, purchasing groups, third-party payers and governmental organizations, intellectual property rights disputes, complex and costly regulation, including healthcare fraud and abuse regulations, manufacturing or supply chain problems or disruptions, rising commodity costs, recalls or safety alerts and negative publicity relating to Covidien or its products, product liability losses and other litigation liability, including legacy Tyco-related litigation, divestitures of some of our businesses or product lines, our ability to execute strategic acquisitions of, investments in or alliances with other companies and businesses, competition, risks associated with doing business outside of the United States, foreign currency exchange rates, issues related to our existing material weakness in accounting for income taxes or potential environmental liabilities. These and other factors are identified and described in more detail in our filings with the SEC. We disclaim any obligation to update these forward-looking statements other than as required by law.
Posted: November 2009
- FDA Extends Review of Pennsaid Diclofenac Sodium Topical Solution - August 5, 2009
- FDA Accepts Nuvo's Resubmission For Pennsaid - February 19, 2009
- Nuvo Provides Update on Discussions with the FDA Related toPennsaid Approval - June 19, 2007
- Nuvo Continues Discussions with the FDA Related to Pennsaid - June 6, 2007
- Nuvo announces further update on discussions with the FDA related to review of Pennsaid - March 7, 2007
- Nuvo Announces Update on Discussions With FDA Related to Approval of Pennsaid - February 9, 2007
- Nuvo Receives Approvable Letter From U.S. FDA for Pennsaid - December 29, 2006
- Nuvo’s Pennsaid NDA Resubmission Accepted for Review by U.S. FDA - July 13, 2006
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