FDAnews Drug Daily Bulletin

The FDA will not require human clinical trials to support the ANDA for Sandoz and Momenta’s generic version of the anticoagulant Lovenox, which previously received a not-approvable letter.

In a regulatory guidance to the companies, the FDA requested additional data from in vitro and in vivo animal tests, more information on certain proposed methods and testing of additional samples. But the agency did not request human trials.

The companies said they expect to submit an amendment to the ANDA, containing the requested data, in the third quarter. Sandoz is developing enoxaparin, a technology-enabled generic version of sanofi-aventis’ Lovenox, in collaboration with Momenta.
 
Earlier this year, the companies submitted a proposal to the FDA for addressing the potential immunogenicity of enoxaparin. The proposal was in response to a 2007 not-approvable letter that said the ANDA did not adequately address that potential.