FDA Holds To High Standards For Insomnia Drugs With Second “Complete Response” For Transcept’s Intermezzo
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
FDA’s second “complete response” letter for Transcept Pharmaceuticals’s Intermezzo continues the strict scrutiny the agency has given recent candidates for sleep maintenance insomnia indications.
You may also be interested in...
Obesity Drugs Go Back To The Drawing Board; FDA To Hold Advisory Committee On CV Risk
FDA will conduct an advisory committee early in 2012 to discuss how to assess the cardiovascular risk of weight-loss drugs, Orexigen revealed June 3 in announcing the firm will halt development in the U.S. of its obesity medication Contrave.
Transcept's NDA Intermission For Insomnia Drug Intermezzo Set To End In First Quarter
Results from a driving impairment study strengthen the case for approval, the company says.
Somaxon Sleep Aid Silenor Not Effective, FDA Says
In its second "complete response" letter for the chronic insomnia drug, FDA says Silenor fails to meet approval standards.