Biotech Values

[DewDiligence]

does such a review [of labeling discussions] take very long…

For a branded drug, labeling discussions can last from a few days to several months. Reviews of generic drugs do not typically have labeling discussions insofar as the label of the generic is typically identical to the label of the corresponding branded drug. That’s why it’s somewhat puzzling that Ampastar would report that it is now in labeling discussions.

…is there significance to the "therapeutically equivalent" language?

“Therapeutically equivalent” presumably means substitutable for branded Lovenox; however, this begs the question of why there is anything about the label that still needs to be discussed.