MISSISSAUGA, Ontario, July 25, 2011 /PRNewswire/ — 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
“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.”
Information about Sublinox
Sublinox is a sublingual orally dissolving tablet of zolpidem
tartrate and will be the first commercially available zolpidem
tartrate formulation in Canada. Sublinox has been clinically
demonstrated to initiate a statistically significant latency to
persistent sleep (LPS), Sleep onset latency (SOL), and Latency to
stage 1 sleep (ST1L) in comparison to oral zolpidem tartrate.
Analysis of sleep continuity endpoints, total sleep time
(TST) and wake after sleep onset (WASO) showed no major treatment
differences in comparison to oral zolpidem tartrate tablets.
About Valeant Pharmaceuticals International, Inc.
Valeant Pharmaceuticals International, Inc. (NYSE/TSX: VRX) is a
multinational specialty pharmaceutical company that develops,