>> Quote:…what do you think of the noticeably different average molecular weights of Lupenox and Lovenox -- 3.9 kDa and 4.5 kDa, respectively -- and what that implies?
The implication is obvious—the drugs are not the same.
Quote:To me it supports genisi's assertion that t-enox is not Lupenox; I just can't see Teva seriously trying to claim sameness with the AMW that far off.
In circa 2002 when Teva inked its deal with ItalFarmaco, MNTA was an unknown private company called Mimeon and no one knew how much sameness the FDA would demand for approval of a Lovenox generic. It’s easy to ridicule Teva’s decision in hindsight, but I see no reason to think that it wasn’t a rational business decision at the time.<<
I'll buy that rationale for that time. But at some point in the ANDA process, FDA had to have told Teva it was flunking on this very basic metric. Teva would then have to modify Lupenox or start over, which is really the same thing: Since the starting material for any LMWH is heparin, starting over means fiddling with the process conditions to at least get near the right molecular weight, and then we are no longer talking about Lupenox -- the product is the process of splitting heparin a certain way. Teva had to have been told by FDA years ago that the Lupenox process would not fly.
To summarize, maybe Teva tried with Lupenox at first. The odds that Teva still is seem extremely remote to me. I've been circumspect to this point, but now I'm just going to come out and say I think your source is full of crap if it's insisting that t-enox is still Lupenox -- if it ever was -- and I am surprised that you believe it.
So the interesting question is when did Teva switch tacks if they started with Lupenox? I'd say the FDA would have put them off of Lupenox circa 2006 at latest. They weren't going to waste time with immunogenicity data on Lupenox. That would give Teva at least a minimum of a year and half to come up with something that had the right active ingredient and molecular weight, at which point the FDA might have been willing to move on.
Regards, RockRat
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