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news.The FDA has delayed its decision on whether or not to approve Wyeth's new antidepressant, DVS-233, by three months after the company submitted new data.
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The FDA’s revised action date for the drug, which is a derivative of the company’s popular Effexor XR, will now be January 22, 2007.
The company said that the FDA has not communicated any new concerns regarding the NDA submission and that the extension is not likely to have any bearing on the current launch plans.
The FDA has the option of extending the typical 10-month review period if a sponsor submits a major amendment, as defined by the FDA, during the last three months of the review.
In this instance, Wyeth had submitted its analyses of preclinical carcinogenicity data in study reports as part of the original NDA in December 2005, and subsequently submitted the raw data sets from these studies.
Wyeth had to resubmit that same raw data in the required format on July 31, 2006, which fell during the last three months of the FDA’s review period. The decision to extend the review period was based solely on the submission of re-formatted data sets, the company said.