Covidien (COV) and Nuvo Research Inc. (NRI.TO) said that the U.S. Food and Drug Administration has set a new action date under the Prescription Drug User Fee Act for Pennsaid or diclofenac sodium topical solution 1.5% w/w of November 4, 2009. During the review process, Nuvo provided the FDA with supplemental information, which the Agency determined to be a major amendment to the Pennsaid New Drug Application. As a result, the FDA has extended its action date by three months to provide time for a full review of the submission.
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