In November 2006, a member of the staff of the FDA’s Office of Generic Drugs called Amphastar to say that Amphastar’s enoxaparin ANDA would be approved within ten to fourteen business days. Despite this verbal assurance, Amphastar’s enoxaparin ANDA remains in limbo.
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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.
The "sameness" finding was subsequently rescinded because of a change in raw materials supplier.
Current hold-up seems to be supply and perhaps immunogenicity.
If the FDA has truly acknowledged "sameness" according to the five criteria as Amphastar claims, then Teva's claim to have achieved sameness must also get a boost in credibility.
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