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Biotech / Medical : Biotech Short Candidates -- Ignore unavailable to you. Want to Upgrade?

To: keokalani'nui who wrote (720)10/16/2004 1:12:59 PM
From: hmpa  Respond to of 897
 
>Since this is not Title IV ANDA, neither the filer nor FDA have to disclose anything related to the filing before approval<

Is that because the patent has already expired?

Yes. Generally, ANDAs for generic products (where there are no patent issues) are not disclosed until approved. I do not know rejection statistics for ANDAs; I was never able to find any info to this regard on FDA site or elsewhere.


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