Nuvo, Paladin deal

In March, Nuvo said the Mallinckrodt Inc. subsidiary of Covidien plc (NYSE:COV, Dublin, Ireland) received a complete response letter for an NDA for Pennsaid 2% to treat osteoarthritis (OA) of the knee. FDA requested a new pharmacokinetic study comparing Pennsaid 2% vs. Pennsaid 1.5% diclofenac. Pennsaid 2%, a topical NSAID gel formulation, is a twice-daily formulation of Pennsaid 1.5%, which is administered four times daily and marketed in the U.S., EU and Canada to treat signs and symptoms of OA of the knee. Mallinckrodt has rights to Pennsaid from Nuvo in the U.S. under a 2009 deal (see BioCentury, June 22, 2009 & March 25, 2013). ...