The FDA had 4 options on this filing at this point:
1) Approve
2) Denied
3) Major Deficiency Letter
4) Minor Deficiency Letter
The point is that there is a deficiency in the filing at this point. It could be anything, but the main thing is that Teva has to answer the question's to the liking of the FDA.
It seems that if Teva gives the FDA the appropriate answers they'll have approval, if not they'll be denied.
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