Impact of Generic The key issues are FDA requirements and timing.
Vancomycin is a highly water soluble drug with poor GI membrane permeability. Generics can request a biowaiver for BCS1 drugs (Biopharmaceutucal Class System 1) based on high solubilty, high permeability. Vancomycin is high solubility/poor permeabilty drug and would normally require a biostudy in order to get FDA approval. Since the drug is not absorbed systemically, the only way to show true bioeqivelence is with a clinical efficay study. I suspect VPHM will submit data to the FDA to show that the formulation is important in efficacy. If this is the case, I would expect FDA to sponsor open hearings on the subject. This could take months for the FDA to decide. If FDA delays decision on this, expect rapid recovery of pps.
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