Advisory committee cancellations
A Psychopharmacologic Drugs Advisory Committee review of Wyeth's pending antidepressant desvenlafaxine scheduled for Sept. 8 has been canceled, Wyeth announces Aug. 22. FDA deemed the meeting unnecessary because "questions that they had were answered with further review of the data," firm says. Company still expects to launch the Effexor follow-on in 2007. The agency also recently cancelled a Sept. 7 psychopharm committee review of J&J's antipsychotic paliperidone (1"The Pink Sheet" July 24, 2006, p. 6). Additionally, Schering-Plough announced Aug. 21 that a planned Sept. 11 Anti-Infective Drugs Advisory Committee review of garenoxacin (proposed trade name Geninax) has been cancelled after the company withdrew the NDA. Schering says it may meet with FDA in the future about a resubmission of the antibiotic...
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