FDA advises that human trials not required for Vancocin generic versions
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FDA advises that human trials not required for Vancocin generic versions
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메디칼라이터팀
입력 2009.08.06 00:00
수정 2009.08.06 09:01
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According to an FDA panel generic drug companies should not have to conduct costly human trials before launching generic versions of ViroPharma"s lead drug Vancocin [vancomycin]. While the company"s executives argued that trials in patients with gastrointestinal infections should be done, the panel was not swayed and voted unanimously for laboratory testing. The decision was a setback to the company as Vancocin is the only FDA-approved therapy for antibiotic-associated gastrointestinal infection and it accounts for the vast majority of ViroPharma"s revenue.