Biotech Values

[dewophile]

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.

actually "sameness" appears in the original complaint. item 23, page 5:

http://www.fdalawblog.net/files/lovenox---amphastar-complaint.pdf

23. Amphastar's Abbreviated New Drug Application remains pending despite reaching "sameness" (a prerequisite for FDA generic drug approval) on november 2,2007...

notably absent is any claim of having met the 5 criteria for sameness

the fact they omitted stating they met the 5 criteria when referencing the nov 2 2007 letter in the original complaint further adds doubt that they actualy met the 5 criteria in 2007. so i have to stand by my original assertion that they extrapolated meeting the 5 criteria based upon a looser definition of "sameness" in 2007