Replies to post #111608 on Biotech Values

[biomaven0]

Highly unlikely that this actually happened.

It's inconceivable to me that Amphastar would lie in a document like this. OGD has historically been something of a loose cannon - look at the incident with generic vancocin as a good example. Quite possible that some low-level OGD guy told them something and then got overruled by the folks at the FDA.

Peter

[mouton29]

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

But they also claim that they received a letter from the FDA acknowledging "sameness," yes, about 2 1/2 years before the "sameness" criteria were released. I checked the docket for the case and don't see an exhibit of said letter. Compare the complaint in the Momenta - TEVA patent litigation, where Momenta attached various documents/call transcripts, etc.

What Amphastar is saying is that the FDA had decided on the five sameness criteria 2 1/2 years before they set those forth in a response to Aventis's 2003 Citizen's petition. Hard to believe.

Note that the complaint was amended between the original filing and the December 22 fling. The original complaint only alleged the various improper FDA behaviors relating to inspections and detention of supplies, etc. and only sought an injunction against that behavior. The amended complaint now adds the allegations about sameness and asks that the FDA be directed to approve the Amphastar ANDA.