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Berlex HRT “not approvable”

Executive Summary

Berlex Labs' hormone replacement therapy Angeliq (drosperinone) deemed "not approvable" by FDA Oct. 17. After public reaction to the Women's Health Initiative study, "it is understandable that it is difficult to assess new HRT preparations," Schering AG maintains. Company's estradiol/levonorgestrel combination patch received a "not approvable" letter Oct. 8 (1"The Pink Sheet" Oct. 14, In Brief)...
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