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Gynetics' Preven

This article was originally published in The Tan Sheet

Executive Summary

Emergency contraceptive could be considered for Rx-to-OTC switch in the coming years, the company indicates. The Rx kit, which includes four levonorgestrel .25 mg/ethinyl estradiol .05 mg pills as well as a pregnancy test and a patient information book, received FDA approval Sept. 2. Speaking at a same-day teleconference, Gynetics Chairman Roderick Mackenzie did not express an immediate desire to pursue a switch, citing market research showing women value the chance for product reimbursement and physician consultation, but said the company would "monitor this together with FDA for the next year or two. As we learn more, we are going to readdress the situation of whether going over-the-counter is appropriate." Rx Preven will be available nationwide in late September; a print/radio consumer ad campaign is planned for October. FDA has shown mild interest in oral contraceptives as switch candidates. An advisory meeting on the topic was scheduled for February 1993, but was postponed to gather input from interested groups...
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