Biotech Values

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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.

However, FDA recinded the "sameness" later in 2008 per the same document.

75. On the basis of this alleged “falsity” – which had no basis in fact – the FDA rescinded its earlier “sameness” finding for Amphastar’s enoxaparin.

78. The FDA’s December 23, 2008 letter indicated that the FDA would force Amphastar to start the ANDA process over completely, allowing the FDA to further delay Amphastar’s entry into the enoxaparin market. The letter said, “It is possible that a major amendment will not remedy the deficiencies in your ANDA, and you may need to withdraw and submit a new ANDA.”