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Replies to #29423 on Biotech Values
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DewDiligence

06/01/06 11:30 AM

#29430 RE: rkrw #29423

>The plus for mnta is the fda refused to approve omnitrope as a true generic and I'd think it's MUCH closer to being an actual copy than any of the others trying with lovenox<

Because the Omnitrope application was a 505b2 rather than an ANDA, I don’t think the FDA had the option of declaring that Omnitrope was a full-fledged generic substitute for Genotropin. If the FDA had done that, PFE might have had a good lawsuit.