Biotech Values

[DewDiligence]

Nowhere does the FDA say that meeting the five criteria for Lovenox sameness is sufficient for FDA approval of generic Lovenox. Rather, the FDA says that the five criteria are “to be used” in the review of a generic-Lovenox application, which I interpret to mean as necessary but not sufficient for FDA approval. Hence, I respectfully disagree with the inferences you are drawing in this thread about how close (or distant) to FDA approval Teva and Amphastar are likely to be.