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ECs in Canada

This article was originally published in The Tan Sheet

Executive Summary

Women's Capital Corp.'s progestin-only morning-after pill, Plan B, could be available "behind-the-counter" in Canada within a year, group says. WCC submitted an application to Health Canada March 6 to switch the EC from prescription-only to nonprescription status; if approved, Plan B would be dispensed by trained pharmacists operating under a protocol developed by the Canadian Pharmacists Association and Society of Obstetricians & Gynecologists of Canada. Application includes results from a label comprehension study of 600 American women, as well as post-marketing safety data from Europe. WCC also is in final stages of an actual-use study involving 600 women in Washington; once it is complete, the group will have enough information to submit an application to FDA, which it plans for late summer...

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