Covidien, a leading global provider of healthcare products, and Nuvo Research Inc, a Canadian drug development company, announced that the US Food and Drug Administration (FDA) has set a new action date under the Prescription Drug User Fee Act (PDUFA) for Pennsaid (diclofenac sodium) topical solution 1.5% w/w of November 4, 2009.

During the review process, Nuvo provided the FDA with supplemental information, which the Agency determined to be a major amendment to the Pennsaid New Drug Application. As a result, the FDA has extended its action date by three months to provide time for a full review of the submission. "We believe we have submitted a high-quality application for Pennsaid and will continue to work closely with the FDA throughout the remaining review process," stated Dan Chicoine, Chairman of Nuvo Research.

"Covidien is committed to the future success of Pennsaid topical solution and we are continuing with our preparations to launch the product anticipating FDA approval," said Timothy R Wright, president, Pharmaceutical Products and Imaging Solutions, Covidien.

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.

In June, the companies announced that Covidien's Mallinckrodt Inc. subsidiary had entered into a license and development agreement with Nuvo that encompasses Pennsaid Topical Solution and another topical formulation of diclofenac now under development.

Under the agreement, Nuvo is responsible for regulatory submissions, owns and maintains the intellectual property, and will be responsible for manufacturing. Covidien is responsible for all commercialization activities, including marketing, selling and medical education.

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.

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.