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Re: biophud post# 59778

Friday, 11/28/2008 3:58:58 AM

Friday, November 28, 2008 3:58:58 AM

Post# of 252498
AZN gets FDA approvable letter (oops—I mean a Complete Response Letter) for Motavizumab:

http://www.reuters.com/article/marketsNews/idINLS22855520081128

Motavizumab is the next-generation version of the blockbuster Synagis.

When was the last time the FDA granted a full-fledged approval on the first review cycle? I’m seriously having a hard time remembering.


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