Health Canada approves Valeant's NDA for Sublinox to treat insomnia

Jul 25 2011

Valeant Pharmaceuticals International, Inc. (NYSE: VRX and TSX: VRX) announced that its wholly owned subsidiary, Valeant Canada Limited, has received notice that the New Drug Submission for Sublinox has been approved from the Canadian regulatory authority Health Canada. Sublinox (zolpidem tartrate) is indicated for the short-term treatment and symptomatic relief of insomnia characterized by difficulty in falling asleep, frequent nocturnal awakenings, and/or early morning awakenings. The product will be commercialized by the joint venture between Meda AB and Valeant Canada Limited (Meda Valeant Pharma Canada Inc.).

"We are excited to receive approval for our second product to come out of our joint venture with Meda," said J. Michael Pearson, chairman and chief executive officer. "With this approval, we currently anticipate launching this product in the fourth quarter, just one of several pending product launches that our Canadian operations plan on initiating before the end of the year."