FDA Extends Review Of Pennsaid Diclofenac Sodium Topical Solution

Covidien and Nuvo have reported that FDA has extended the review of Pennsaid diclofenac sodium topical solution under the Prescription Drug User Fee Act (PDUFA).

During the review process, Nuvo has provided FDA with supplemental information, which the Agency determined to be a major amendment to the Pennsaid New Drug Application. As a result, FDA has extended its action date by three months to provide time for a full review of the submission.

In June, Covidien and Nuvo announced that the Mallinckrodt 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.

Dan Chicoine, chairman of Nuvo, said: 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.