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Clinical Program Home |
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| Clinical Program |
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PhytoCeutica’s core focus is getting the first oral botanical-based
prescription drug approved by the FDA. The FDA’s recent
publication Guidance for Industry Botanical Drug Products
provides an overarching description of the regulatory pathway
botanical drugs must take to gain regulatory prescription
approval. This framework
is similar to that for synthetic or highly
purified drugs: |
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| However, the details requisite for a successful navigation of this pathway remain undefined. PhytoCeutica will work closely with FDA as its lead product. PHY906, makes its way through the various clinical phases. An Investigational, New Drug Application (IND) for PHY906 was filed May 2001. To date, two clinical trials in
colorectal and
primary liver cancers have been initiated under IND 62627.
Upcoming trials have been initiated or are planned for 2007 and beyond. |
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