Paladin Labs, Somaxon Pharmaceuticals' licensee, has obtained Health Canada approval for Silenor new drug submission.
Silenor, a low-dose doxepin oral tablet formulation, is developed to treat insomnia and symptoms such as frequent nocturnal awakening and/or early morning awakenings.
Somaxon president and chief executive officer Richard Pascoe said, "We look forward to Paladin's launch of Silenor, which is expected to occur in the middle of 2013."
In June 2011, Somaxon granted Silenor commercialization rights in Canada, South America and Africa to Paladin.
Clinical trials demonstrated effective sleep maintenance of Silenor in insomnia patients without any residual effects the following day.
Source:
http://regulatoryaffairs.pharmaceutical-business-review.com/news/health-canada-approves-paladin-silenor-new-drug-submission-181212
