Replies to post #111602 on Biotech Values

[DewDiligence]

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.

The five criteria for approval set forth in the FDA’s response to SNY’s CP were not even codified in Nov 2007, when Amphastar claims to have been told it had achieved sameness. Therefore, a reasonable interpretation of events is not that Amphastar and Teva are close to approval, but rather that chemical sameness is not a consequential achievement.

[DewDiligence]

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.

Highly unlikely that this actually happened. If it had really happened, Amphastar would be able to name the OGD staffer who called.

[ghmm]

Thanks for posting the info and link. In reading through it paragraph 78 would seem to indicate the sides are far apart which would be consistent with the WSJ mention #msg-56531176

[jq1234]

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 On the basis of this alleged “falsity” – which had no basis in fact – the FDA rescinded its earlier “sameness” finding for Amphastar’s enoxaparin.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