Pristiq
desvenlafaxine
Treatment for DepressionRe-formatted Data Submission Results in Extension of FDA Review for Desvenlafaxine Succinate
MADISON, N.J., August 29, 2006 -- Wyeth announced today it has been notified by the U.S. Food and Drug Administration (FDA) that the agency has extended by three months the action date for its review of the New Drug Application (NDA) for desvenlafaxine succinate extended release for the treatment of major depressive disorder. The FDA's revised action date for the NDA for desvenlafaxine succinate will now be January 22, 2007.
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 pre-clinical 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 Agency has not communicated any new concerns regarding the NDA submission. This extension is not likely to have any bearing on the current launch plans.
Source: Wyeth
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