Biomaven,
""On November 2, 2007, the FDA acknowledged, in a letter to Amphastar from the Office of Generic Drugs, that Amphastar had met the FDA’s five “sameness” criteria and therefore had demonstrated its enoxaparin’s sameness with Lovenox® in its ANDA.""
Mouton,
""I checked the docket for the case and don't see an exhibit of said letter.""
Dew,
...If true, why is Amphastar proceding like this?
tia
y3