Somaxon Sees “Clear Path” For Silenor Sleep Aid Switch
This article was originally published in The Tan Sheet
Somaxon Pharmaceuticals expects to make Silenor sleep aid available OTC in five to seven years.
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Procter & Gamble's license to market the insomnia drug Silenor lets the firm re-enter the Rx drug market without development costs and opens the door to a potential OTC switch
Somaxon hopes to launch its insomnia drug in the second half of 2010, but is still searching for a U.S. commercial partner.
In its second "complete response" letter for the chronic insomnia drug, FDA says Silenor fails to meet approval standards.