Covidien (NYSE:COV), a leading global provider of healthcare products, and Nuvo Research Inc. (TSX:NRI), 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.”