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Covidien (NYSE:COV): Closing price $64.71
Nuvo Research said that its United States licensing partner, Mallinckrodt, which is the Pharmaceuticals Business of Covidien, has received a Complete Response Letter from the FDA after the review of Mallinckrodt’s New Drug Application for diclofenac sodium topical solution, 2% w/w. In the letter, the FDA says that Mallinckrodt must successfully complete a pharmacokinetic study comparing Pennsaid 2% to original Pennsaid 1.5 percent. Similar pharmacokinetic studies submitted by Mallinckrodt with the NDA were not acceptable to the FDA as reserve samples were not retained at the clinical site. Mallinckrodt has indicated that it expects to complete the study and submit the results to the FDA in the third quarter of 2013, and that it expects that the FDA will provide a formal response to the filing within 6 months thereafter. Shares closed up 1.17 percent on the day $64.71, and have traded in a 52-week range of $50.25 to $64.04.
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