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.
저작권자 © 메디칼업저버 무단전재 및 재배포 금지