Replies to post #101745 on Biotech Values

[Mpower]

wish i could see that. I am interested to see how the FDA responded to the irreparable harm/sovereign immunity argument set forth by Sanofi.

A PI, if granted, would likely cause irreparable harm to Sandoz. Thus, granting of one is likely "a wash", and I suspect the judge would want to maintain the status-quo. (thats my guess as a non-practicing attorney). It helps that the judge already refused to issue a TRO at the scheduling conference.

I wonder what the FDA said in their surreply to Sanofi's sovereign immunity argument...

[DewDiligence]

Index to Legal/Regulatory Documents for Generic Lovenox

[Added 8/16/10 FDA surreply and addendum re impurity testing.]


The following documents are in chronological order (except bottommost item):

FDA 7/23/10 brief monograph on approval of generic Lovenox (1 page)

FDA 7/23/10 response to Sanofi Citizen Petition (45 pages)

Sanofi 7/26/10 complaint against FDA (14 pages)

Sanofi 7/26/10 motion for temporary restraining order and preliminary injunction (50 pages)

FDA 8/4/10 response to Sanofi complaint (56 pages)

Sandoz 8/6/10 response to Sanofi complaint (36 pages)

Sanofi 8/11/10 follow-up in reply to FDA/Sandoz pleadings (31 pages)

FDA 8/16/10 surreply to Sanofi reply of 8/11/10 (19 pages)

Addendum to FDA 8/16/10 surreply re impurity testing (12 pages)

Teva 8/20/04 Citizen Petition (7 pages)