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
You may also be interested in...
Somaxon’s Silenor Could Launch In Early ’09 Pending Partnering Discussions
Somaxon submits an NDA for the insomnia medication, setting it up for potential FDA approval in December, firm tells "The Pink Sheet" DAILY.
Somaxon Could Fold Gambling Drug Development Following Negative Trial Results
Company will also assess results of nalmefene studies in smoking cessation before deciding on drug’s future.
Madrigal’s FDA Approval In MASH Ends Years Of Industry Frustration
As the first approved MASH (formerly NASH) therapy, nearly four years after initially anticipated, Madrigal gets the opportunity to establish a MASH marketplace with Rezdiffra (resmetirom).