>>Still if M-Enoxaparin is a more homogenous version of Lovenox
MNTA claims to have produced m-enoxaparin which accurately duplicates all (those over 0.5%) components of of enoxiparin.
The FDA's action seems to be a negative pregnant. The vary act of requesting immunogenicity data of MNTA implies that "sameness" has been obtained.
Yet as far as we know, only MNTA has received a not approvable letter and a request* for immunogenicity data. We could argue that until "sameness" is attained, that there is no reason for the FDA to request immunogenicity data. That would explain** no request for this data from Teva or Amphastar.
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* ``In a follow-up call, the FDA clarified that all applications for enoxaparin products must address the potential for immunogenicity of the drug product. We believe that we can address what we anticipate to be the FDA's concerns, based on our detailed characterization of enoxaparin and on the current medical and scientific literature,'' said Craig A. Wheeler, President and Chief Executive Officer.
** Of course this is not the ONLY explanation - perhaps the same request has been made and not disclosed.
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