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In Brief: Apothecus Pharmaceutical

This article was originally published in The Tan Sheet

Executive Summary

Apothecus Pharmaceutical: Informs FDA in a July 26 letter that the company will forward the protocol for an upcoming study using its VCF Vaginal Contraceptive Film to agency. The open-label, prospective, parallel group, randomized, multicenter clinical trial will compare VCF to a foaming tablet contraceptive and will be conducted by Family Health International. FDA's Feb. 3 tentative final monograph requires approved NDAs in order to continue marketing OTC vaginal contraceptive products ("The Tan Sheet" Feb. 6, pp. 2-4). Apothecus, which sells VCF to public agencies for distribution to inner-city teens, has opposed the requirement because of the high costs associated with conducting clinical trials ("The Tan Sheet" June 19, p. 9)...

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