Could be that over bio-availability could garner an AB too, I guess?
I need to take off here, but I did find <a href="http://www.fda.gov/cder/orange/adppreface.htm">this little nugget</a> which includes this section:
<b>1.8 Description of Special Situations</b>
Certain drugs present special situations that deserve a more complete explanation than can be provided by the two-letter codes used in the List. These drugs have particular problems with standards of identity, analytical methodology, or bioequivalence that are in the process of resolution. The following drugs are in this category:
<i>Ribavirin 200mg Oral Capsule. Indicated for use and comarketed with interferon alfa-2b, recombinant (Intron A), as Rebetron Combination Therapy.</i>
I did not search for the 'more complete explanation'.
(here's the table from the non-working link - though there's no telling if it will look anything like a columnar table once it's posted. Here goes....)
Proprietary Name Search Results from "OB_Rx" table for query on "ribavirin."
Appl
# TE Code RLD Act. Ingrdt. Dsg Form;Route Strength Proprietary
Name Applicant
076192 AB No RIBAVIRIN CAPSULE; ORAL 200MG RIBAVIRIN SANDOZ
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076277 AB No RIBAVIRIN CAPSULE; ORAL 200MG RIBAVIRIN TEVA
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077224 AB No RIBAVIRIN CAPSULE; ORAL 200MG RIBAVIRIN ZYDUS PHARMS USA
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077053 AB No RIBAVIRIN TABLET; ORAL 200MG RIBAVIRIN TEVA
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077456 AB No RIBAVIRIN TABLET; ORAL 200MG RIBAVIRIN THREE RIVERS PHARMS
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077094 AB No RIBAVIRIN TABLET; ORAL 200MG RIBAVIRIN ZYDUS PHARMS USA
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077456 No RIBAVIRIN TABLET; ORAL 400MG RIBAVIRIN THREE RIVERS PHARMS
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077456 Yes RIBAVIRIN TABLET; ORAL 600MG RIBAVIRIN THREE RIVERS PHARMS
Thank you for sending us the interesting reads!
Hope you are doing great.
I live in an apt but they are going to be opening a community garden a few blocks from here, and I'm going to rent a plot, so maybe I'll be asking you guys for tips...want to grow some winter veggies...since it's been in the 80's here almost all winter it seems like, don't know how "winter" it's going to be...
what a relief to see we are still in the news! Thanks tnguy!
hey chev, have you ever had tomatoes come out on their own after the winter? the last two springs I have found little shoots coming out on their own after the cold. I have transplanted them, and they got as big and yielded as much as the saplings we have bought from the farmer. It is like a little miracle of life, those seeds surviving that much hardship. The first yr my boyfriend laughed at me, for thinking I would get anything from those tiny, almost microscopical things. Boy, did nature show him! last yr, he did not laugh at me.
A couple of things that stand out in the Procrit study that may account for the lower SVR figures:
- African Americans made up approximately 39% of the overall participants. As a group they tend to have much lower SVR rates (though those on high-dose riba did well here). And 39% is more than triple of their actual representation as a percentage of U.S. population (around 11-12%).
- Group 1 had a 60% discontinuation rate
- Group 2 had a 73% discontinuation rate
- Group 3 had a 49% discontinuation rate
These tx discontinuation rates - especially for groups 1 and 2 - would seem to be rather high.
As "goofydad" has said, probably the most beneficial information to glean from this study is the importance of (higher) riba dosage, as well as early Procrit intervention to help maintain those higher does amounts.
TnHepGuy