I forget the details, but at some point wasn't there some labeling issue that related to an IP issue - some indication that initially wasn't going to be included until an exclusivity period for that use ended?
TEVA(MNTA): "It is Teva’s intention to submit the PD study results for Agency review as part of our pending ANDA for enoxaparin sodium injection." ---Note usage of the key operator "intention."
...unless they were referring to in vitro testing, we know PD studies cannot be used to support a non-AB rated generic
---It is unknown what the FDA will allow. The thread involving Teva possibly getting a non AB-rated approval is still valid, imo. The thread involving Teva walking away empty-handed (and not caring) is also alive.
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