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Zolinza (vorinostat) capsules
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- September 2009
WARNINGS AND PRECAUTIONS
QTC Prolongation (removed)
- A randomized, partially-blind, placebo-controlled, 2-period crossover study was performed to assess the...
- In clinical studies in patients with CTCL, three of 86 CTCL patients exposed to 400 mg once daily had Grade 1 (>450-470 msec) or 2 (>470-500 msec or increase of >60 msec above baseline) clinical adverse..