Teva's letter specifies that the rings in their generic were "similar" to that of Aventis/Sanofi, and that additional studies thereon were on-going and would be submitted.
Teva does admit that they have not fully characterized the molecule (by clear inference) and they discount the newly discovered chains as falling under the legal classification of "no clinical significance". Whereas Aventis "speculates" these newly characterized chains do have clinical significance, such as a half-life difference on their anti-Xa activity.
Teva basically stating that all these newly discovered chains "potential clinical significance is doubtful".
I would imagine that MNTA discovered quite a few more than Aventis/Sanofi brought up in their citizen petition.
In any event, my point made. I think Teva has to convince the FDA that the disparities in Teva's formulation, disparities that were probably primarily revealed from MNTA's applicatio and characterization of the drug, are without clinical significance.
The FDA monograph however seemed pretty clear that the FDA had some real concerns about these chains. The historical article on Premarin is consistent with this view point as that is how the FDA treated the generic appliations for Premarin. If there were new chains discovered, and we suspect they may alter the characteristics of the drug, then the applicant has to prove to us otherwise that they are clinically insignificant before we will approve their drug.
When I talk this much we are usually in trouble. Logically, in context with everything I've seen, this is a proper analysis. The real key lies in what is going on in the real world with Teva and the FDA. I still don't think Teva has a sufficient drug, unless they can prove to the FDA that all these new strands that MNTA characterized in Lovenox, and which were mentioned in the FDA monograph, can be shown to be clinically insignificant or otherwise replicated in Teva's drug.
Tinker
AI
