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Berlex, FDA Discuss HRT Patch Data Documentation After "Not Approvable"

Executive Summary

Berlex and FDA are discussing the agency's requirements for data documentation so that the company may resubmit the NDA for its estradiol/levonorgestrel transdermal patch.

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Schering AG estradiol/levonorgestrel transdermal combination patch deemed "not approvable" by FDA Oct. 8, Schering AG says. The NDA, originally filed June 29, 2000, received a previous "not approvable" letter in June 2001 (1"The Pink Sheet" July 9, 2001, p. 19)...

Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011



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