Biotech Values

[biomaven0]

>>which Amphastar disclosures are you referring to?

Their amended complaint:

http://208.78.96.220/Amphastar_4-25-11.pdf

In particular this paragraph:

46. 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.