Silenor could be the first and only prescription therapy for insomnia in Canada that is not a controlled substance, if approved.
Paladin has gained commercialization rights to Silenor in Canada, South America and Africa from Somaxon in June 2011.
Silenor is a low-dose (3mg and 6mg) oral tablet formulation of doxepin.
Paladin interim president and CEO Mark Beaudet said that Health Canada has accepted to review the company’s submission for Canadian regulatory approval for Silenor.
"We believe that Silenor can fill a significant unmet need in the Canadian insomnia market," Beaudet added.