>do you think the antitrypsin product could be approved without going through the formal approval process?<
No—all new drugs from GTC will need formal regulatory approval.
>According to my friends at Talecris there has never been a formal study on this [AAT] product.<
That’s news for me. We know from a PR last year that Talecris is seeking FDA approval for its AAT product that uses the latest manufacturing techniques: #msg-11829819. If the AAT from Talecris (formerly from Bayer) using the older manufacturing techniques was never formally approved by the FDA, it must be so old that it was “grandfathered in” along with such drugs as ABT’s Synthroid.
-- Since you have a contact at Talecris, you might want to inquire how their Thrombate brand of plasma-derived antithrombin is doing. Last year, they seemed to be making a concerted effort to improve the product’s visibility. T.i.a. for any info you can glean. Regards, Dew
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