Biotech Values

[RockRat]

>>Sanofi alleges that FDA's approval of Sandoz’s ANDA violated the Administrative Procedure Act (“APA”) and was improper under the FDC Act insofar as “FDA approved Sandoz's ANDA for a fully substitutable generic version of Lovenox notwithstanding the fact that the Agency required Sandoz to submit additional data and information demonstrating the safety and effectiveness of its product.” According to Sanofi, FDA disregarded FDC Act § 505(j)(2)(A), which concerns the required content of an ANDA and “specifically precludes FDA from requiring the submission of such [safety and effectiveness] information.”<<

I fail to see where Sanofi has standing here. They are the beneficiaries of this delay. It's Momenta & Sandoz that have cause for suit under this clause, as I read it.

>>Moreover, requiring or considering such information as part of an ANDA “effectively allows the generic applicant to rely upon the pioneer's confidential commercial information in a manner not contemplated by the statute,” according to Sanofi. <<

Huh? Where is the connection between the FDA requiring immunogenicity data of generic applicants and confidential commercial info relating to the branded drug?

Regards, RockRat