January 30, 2006...Several U.S. news reports in recent days regarding possible over-the-counter sales of Xenical® have prompted questions from some of our customers. These reports have included coverage on the Internet, radio and in print, as well as stories on Canadian and U.S. network news programs (including CTV, Sun/City, CNN, ABC, CBS and NBC).
Here are the facts as we know them today:
- On January 23rd, a joint advisory committee of the U.S.’s Food and Drug Administration (FDA) recommended the over-the-counter sale of the active ingredient contained in Xenical® (orlistat).
- This recommendation applies to a yet-to-be marketed 60mg strength of the drug. Currently, only a 120mg strength has been approved for use in the U.S. and Canada.
- The FDA is expected to take several months to consider the committee’s recommendation before making a final decision on this matter.
- At this time, Xenical® continues to require a prescription for sale in Canada. Health Canada has not approved any strengths of Xenical® other than the 120mg strength currently marketed. There have not been reports that over-the-counter sales are being considered in Canada.
The FDA advisory committee recommendation has no effect on any Green Shield Canada offerings or plan designs. We will continue to adhere to Health Canada’s guidelines for this drug.
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