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March 5, 2013
07:04 EDTCOVNuvo Research announces FDA response to Pennsaid 2% NDA
Nuvo Research announced that its U.S. licensing partner, Mallinckrodt, the Pharmaceuticals Business of Covidien, has received a Complete Response Letter from the FDA following the review of Mallinckrodt's New Drug Application for diclofenac sodium topical solution, 2% w/w. In the letter, the FDA requires that Mallinckrodt successfully complete a pharmacokinetic study comparing PENNSAID 2% to original PENNSAID 1.5%.Similar pharmacokinetic studies submitted by Mallinckrodt with the NDA were not acceptable to the FDA because reserve samples were not retained at the clinical site. Mallinckrodt has indicated to Nuvo that it expects to complete the study and submit the results to the FDA in the third calendar quarter of 2013, and that it anticipates the FDA will provide a formal response to the filing within 6 months thereafter.
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