FDA Approves Pennsaid® Topical SolutionT. LOUIS & MISSISSAUGA, Ontario--(BUSINESS WIRE)--Covidien (NYSE:
COV -
News), a leading global provider of healthcare products,and Nuvo Research Inc. (TSX:
NRI -
News), a Canadian drug development company,today announced that the U.S. Food and Drug Administration (FDA) hasapproved the New Drug Application for Pennsaid
® TopicalSolution (diclofenac sodium topical solution) 1.5% w/w.
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Pennsaid Topical Solution is a non-steroidal anti-inflammatory drug(NSAID) used for the treatment of the signs and symptoms ofosteoarthritis of the knee.
Nuvo develops drug products delivered to and through the skin using itstopical and transdermal drug delivery technologies. Covidien is thelargest supplier of controlled pain medications in the United Statesbased on number of prescriptions.
“FDA approval of Pennsaid is the most significant milestone in Nuvo’shistory,” said Dan Chicoine, Chairman of Nuvo Research. “We are thrilledthat we have been able to successfully navigate a very challengingregulatory pathway for this product and look forward to the upcominglaunch of Pennsaid in the U.S. by Covidien. This will support thedevelopment of our product pipeline as we progress toward becoming theglobal leader in the research and development of drug products deliveredto or through the skin.”
“Building on more than a century of pain treatment experience, Covidienis focused on expanding the limits of pain therapy by combining provendrugs with innovative delivery systems,” said Timothy R. Wright,President, Pharmaceuticals, Covidien. “We are pleased to becollaborating with Nuvo Research on this opportunity to expand ourbranded pharmaceutical portfolio by selling and marketing Pennsaidthroughout the United States.”
In June, the companies announced that Mallinckrodt Inc., a Covidiencompany, had entered into a license and development agreement with Nuvothat encompasses Pennsaid Topical Solution and its follow-on topicaldiclofenac formulation, Pennsaid® Plus Gel, which iscurrently under development. Under the agreement, Covidien isresponsible for all U.S. commercialization activities, includingmarketing, selling and medical education and is responsible for theclinical development of Pennsaid Plus. Nuvo owns and maintains theintellectual property rights to the products and also will beresponsible for manufacturing.
The launch of Pennsaid Topical Solution, which Covidien anticipates inthe first half of calendar 2010, will include a NSAID medication guidefor prescribers, pharmacists and patients.
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