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News Breaks | | | | March 5, 2013 | | 07:04 EDT |  | COV | Nuvo 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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News For COV From The Last 14 Days Check below for free stories on COV the last two weeks. |
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| June 17, 2013 | | 07:02 EDT | | COV | Covidien announces publication of final results of Pipeline study
Covidien announced that the final results of the PUFs, Pipeline for Uncoilable or Failed Aneurysms, clinical study of its Pipeline embolization device have been published in the June issue of Radiology, the official peer-reviewed medical journal of the Radiological Society of North America. The Pipeline device met the trial’s primary endpoints for both effectiveness and safety. Based on these data, the Pipeline device was approved by the U.S. Food and Drug Administration on April 6, 2011. | |
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