Replies to post #99991 on Biotech Values

[RockRat]

Here's what I found in the FDCA:

>>Section 505 j(2)(C):

"(C) If a person wants to submit an abbreviated application for a new drug which has a different active ingredient or whose route of administration, dosage form, or strength differ from that of a listed drug, such person shall submit a petition to the Secretary seeking permission to file such an application. The Secretary shall approve or disapprove a petition submitted under this subparagraph within ninety days of the date the petition is submitted. The Secretary shall approve such a petition unless the Secretary finds—
(i) that investigations must be conducted to show the safety and effectiveness of the drug or of any of its active ingredients, the route of administration, the dosage form, or strength which differ from the listed drug; or
(ii) that any drug with a different active ingredient may not be adequately evaluated for approval as safe and effective on the basis of the information required to be submitted in an abbreviated application."<<

Nothing else matched up in my search of the Act, but I haven't seen the court papers to see which section Sanofi is actually citing. My view is that the FDA will take the position that for mEnoxaparin none of the items listed in the first sentence are different from the branded version. As such, this argument won't apply. Anyone see this differently?

Here's the Act for those who want to check my search:

http://www.fda.gov/regulatoryinformation/legislation/federalfooddrugandcosmeticactfdcact/default.htm

Edit: Did a recheck myself, and found some more pertinent stuff in section 505 (j)(4), but it seems to recap (2)(C) very closely.

Regards, RockRat

[DewDiligence]

SNY is plainly mischaracterizing the FDA’s review of NVS/MNTA’s Lovenox ANDA, IMO.

Whereas SNY argues that the FDA’s Nov 2007 request for in vitro immunogenicity data on NVS/MNTA’s drug was effectively a request for data on safety and efficacy, I would assert that it was no such thing. Rather, I would characterize the FDA’s request for in vitro immunogenicity data as a way to verify the manufacturing purity of NVS/MNTA’s drug.

Verification of manufacturing purity is a regular feature of generic-drug applications, and hence there was no variance from the governing statues as SNY alleges.