Replies to post #126751 on Biotech Values

[DewDiligence]

…“pending review of labeling matters”…

So it’s not actually approved yet, which explains why there is no press release from the FDA.

[DewDiligence]

“Therapeutically equivalent” means substitutable, according to the FDA’s lexicon. However, the fact that Amphastar and the FDA are still in labeling discussions (according to Amphastar) makes it less than crystal clear what the outcome will be.