BioCentury
ARTICLE | Clinical News

Diclofenac regulatory update

January 27, 2014 8:00 AM UTC

FDA approved a resubmitted NDA from Mallinckrodt for Pennsaid 2% diclofenac to treat osteoarthritis (OA) of the knee. Pennsaid 2%, a topical NSAID gel formulation, is a twice-daily formulation of Pennsaid 1.5%, which is administered 4 times daily and marketed in the U.S., EU and Canada to treat signs and symptoms of OA of the knee. Partner Nuvo Research anticipates that Mallinckrodt will launch Pennsaid 2% in the U.S. this quarter. ...