MISSISSAUGA, Ontario — Nuvo Research on Friday announced that the U.S. Food and Drug Administration approved Mallinckrodt's new drug application for Pennsaid (diclofenac sodium topical solution) 2%.
Pennsaid 2% is a follow-on product to original Pennsaid 1.5%, which has been marketed by Mallinckrodt in the United States since 2010. Pennsaid 2% will be the first twice-per-day dosed topical NSAID available in the United States for the treatment of the pain of osteoarthritis of the knee. Nuvo has licensed the U.S. sales and marketing rights for both Pennsaid 1.5% and Pennsaid 2% to Mallinckrodt.
"The approval of Pennsaid 2% is a significant milestone for Nuvo," said Dan Chicoine, chairman and co-CEO of Nuvo Research. "We are pleased that the FDA has approved this product for patients suffering from the pain of osteoarthritis of the knee."