Silenor "Complete Response" Letter Hints At Efficacy Issues
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Somaxon's last-minute conference call announcing FDA's "complete response" letter for the insomnia agent Silenor (doxepin) did little to clarify whether the agency's concerns have to do with efficacy issues or whether FDA just wants more data on doxepin's potential to prolong the QT interval. Somaxon announced the action letter late on Feb. 26
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