Q: How will investors know whether Teva or Amphastar get approval for generic Lovenox?
A: Teva/Amphastar have first to file status on generic Lovenox, which prevents Sandoz/MNTA from simply launching generic Lovenox upon FDA approval. Thus, if Sandoz/MNTA get FDA approval, investors will know the status of the ANDA’s from Teva and Amphastar by the actions Sandoz/MNTA undertake to deal with the six-month marketing exclusivity conferred by first-to-file status.
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