Diclofenac regulatory update

Earlier this month, Nuvo Research said Covidien's Mallinckrodt Inc. subsidiary received a complete response letter for an NDA for Pennsaid 2% diclofenac sodium to treat osteoarthritis (OA) of the knee. In the letter, FDA said that 2 pharmacokinetic studies submitted by Mallinckrodt were not acceptable because its CRO failed to retain samples at the clinical site, which is a breach of study protocol and FDA regulations. FDA requested a new pharmacokinetic study comparing Pennsaid 2% vs. Pennsaid 1.5% diclofenac. Nuvo Research expects Mallinckrodt will begin the study next month and submit the data to FDA in 3Q13. ...