That’s why no applicant other than NVS/MNTA has obtained FDA approval or is even close to obtaining it despite elapsed time of more than one year since the FDA published the Lovenox sameness criteria in Jul 2010.
Given that TEVA has now gone dark on the subject of tLovenox I don't see that there any way to say much about how 'close to obtaining approval' it is - other than reading of very faint tea leaves. Did I miss something?
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