Tuesday, August 04, 2009 5:31:11 PM
Tue Aug 4, 2009
* Advisory panel votes 16-0 in favor of FDA rules
* ViroPharma opposes FDA plan
SILVER SPRING, Md., Aug 4 (Reuters) - U.S. advisers on Tuesday backed Food and Drug Administration testing guidelines for generic versions of the antibiotic Vancocin over the objections of manufacturer ViroPharma Inc (VPHM.O).
ViroPharma argued to the panel that the FDA's proposed criteria for generic rivals were not stringent enough to prove the copycat versions would work the same in the body as the brand-name product.
But panel members said they felt confident in the FDA's proposed methods for evaluating generic versions with the same active and inactive ingredients as Vancocin. The committee voted 16-0 to back the FDA plan.
The drug's generic name is vancomycin. (Reporting by Lisa Richwine; Editing by Leslie Gevirtz)
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