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Plan B

This article was originally published in The Tan Sheet

Executive Summary

Label comprehension studies for emergency contraceptives continue with mall intercept interviews slated to begin June 5. Changes were made to label after initial study phase, during which labels were shown to interviewees, Women's Capital Corp. says. Following analysis of mall intercept results, WCC will consult with FDA to develop label for actual use study in preparation for Rx-to-OTC switch NDA. Also, nonprescription sales of British analogue, Schering Health Care's Levonelle, under threat as Society for the Protection of Unborn Children secures UK High Court review June 12. Sales of Levonelle, which became available through pharmacists in January, have increased 2%-5% monthly, with one-quarter of total sales coming from non-Rx users, Schering says
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