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Comments on the Viropharma Response to FDA Guideline on Generic Vancocin

March 26, 2009

Analysis of:ViroPharma Submits Comments on Vancocin(R) Draft Bioequivalence Guidance | phx.corporate-ir.net

This is an important response to the FDA proposed guideline on generic Vancocin. The arguments put forward by Viropharma are not new, but are nevertheless well reasoned. It will be interesting to see the extent to which these arguments are successful in changing the proposed policy. The FDA has departed from its usual policy for generics by not requiring the conduct of a bioequivalence study in human volunteers, and instead relying on in vitro dissolution data. Whilst dissolution data are helpful, they are frequently found to be not exactly predictive when developing generics. Frequently several 'tweaks' are needed to the formulation with repetition of the bioequivalence study before a final bioequivalent version of the originator is developed. There is no reason to believe that this formulation would be any different. In fact, there is reason to suspect that blood levels of Vancocin may be observed in individuals that have diseased gastro intestinal tracts. We need to see data.

Possible reasons for the withdrawal of the Shire application in Europe

March 26, 2009

Analysis of:Shire Withdraws European Application For DAYTRANA(TM) (Methylphenidate Transdermal System) | www.medicalnewstoday.com

Companies spend a lot of time and resources preparing submissions for health authorities. To withdraw an application to a major regulatory authority indicates that there was an iminent rejection, or that the application that was filed was not approvable.

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