Jazz anxious to launch once-daily Luvox CR
This article was originally published in Pharmaceutical Approvals Monthly
Jazz Pharmaceuticals anticipates launching its social anxiety and obsessive compulsive disorder drug in the first quarter despite an FDA request for clarification on chemistry, manufacturing and controls in an "approvable" letter received Dec. 21 - the second for controlled-release Luvox CR (fluvoxamine maleate). The firm added 125 sales reps in the fourth quarter in anticipation of approval. CEO Sam Saks acknowledges the launch could be delayed by six months if FDA requests more data, but is hopeful that "this issue can be resolved rapidly"...
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