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www.accessdata.fda.gov/.../022567Orig1s000SumR.pdf M E M O R A N D U M DEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG EVALUATION AND RESEARCH DATE: January 18, 2011 FROM: Thomas P. Laughren, M.D. Director, Division of Psychiatry Products HFD-130 SUBJECT: Recommendation for approval action for vilazodone tablets as a treatment for major depressive disorder (MDD). TO: File NDA 22-567 [Note: This overview should be filed with the 3-22-10 original submission of this NDA.] |
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