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news.Covidien and Nuvo Research (Nuvo) have announced that the FDA has approved the New Drug Application for Pennsaid Topical Solution (diclofenac sodium topical solution) 1.5% w/w.
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Pennsaid Topical Solution is a non-steroidal anti-inflammatory drug used for the treatment of the signs and symptoms of osteoarthritis of the knee.
Dan Chicoine, chairman of Nuvo Research, said: ”FDA approval of Pennsaid is the significant milestone in Nuvo’s history. We have been able to navigate regulatory pathway for this product and look forward to the upcoming launch of Pennsaid in the US by Covidien. This will support the development of our product pipeline.”
Timothy Wright, president of Pharmaceuticals at Covidien, said: ”Covidien is expanding the limits of pain therapy by combining proven drugs with delivery systems. We are pleased to be collaborating with Nuvo Research on this opportunity to expand our pharmaceutical portfolio by selling and marketing Pennsaid throughout the US.”
In June, the companies announced that Mallinckrodt, a Covidien company, 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.
Nuvo develops drug products delivered to and through the skin using its topical and transdermal drug delivery technologies.
Covidien is a global supplier of controlled pain medications.