FDA EXTENDS REVIEW OF WYETH'S NDA DUE TO NEW DATA

Wyeth has been notified by the 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 new date is Jan. 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 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, 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 reformatted data sets.