BioCentury
ARTICLE | Clinical News

Silenor doxepin regulatory update

December 24, 2012 8:00 AM UTC

Health Canada approved an NDS from Paladin Labs Inc. (TSX:PLB, Montreal, Quebec) for Silenor for the treatment and symptomatic relief of insomnia characterized by frequent nocturnal awakening and/or early morning awakenings. Paladin plans to launch the low-dose tricyclic doxepin in mid-2013. Last year, Somaxon granted Paladin exclusive rights to commercialize the product in Canada, South America and Africa (see BioCentury, June 13, 2011). Silenor is marketed in the U.S. to treat insomnia characterized by difficulty with sleep maintenance. ...