FDAnews
www.fdanews.com/articles/75914-momenta-pharmaceuticals-files-anda-for-enoxaparin

MOMENTA PHARMACEUTICALS FILES ANDA FOR ENOXAPARIN

August 30, 2005

Momenta Pharmaceuticals announced that an abbreviated new drug application (ANDA) seeking marketing approval of M-Enoxaparin has been filed with the FDA. Momenta is developing M-Enoxaparin, a technology-enabled generic version of Lovenox, in collaboration with Sandoz, the generics division of Novartis.

Approved for the prevention and treatment of deep vein thrombosis and treatment of acute coronary syndromes, Lovenox (enoxaparin sodium injection) is a widely prescribed low molecular weight heparin.