Nuvo Says Mallinckrodt Submits Pharmacokinetic Study Result Of PENNSAID 2% ToFDA

(RTTNews) - Specialty pharmaceutical company Nuvo Research Inc. (NRI.TO), Thursday said that its US licensing partner for PENNSAID 1.5% and PENNSAID 2%, Mallinckrodt (MNK), has submitted the results of a pharmacokinetic study to the U.S. Food and Drug Administration, or FDA, in support of its New Drug Application for PENNSAID 2%.

This follows the Complete Response Letter Mallinckrodt received from the FDA on March 4, in which the FDA required that Mallinckrodt complete a PK study comparing PENNSAID 2% to original PENNSAID. Mallinckrodt completed the PK study and on August 7, it submitted the clinical study report to the FDA. The FDA is expected to advise Mallinckrodt if the resubmission is acceptable for review within 14 days of the filing and to provide a formal response to Mallinckrodt within 6 months of the filing, Nuvo said.