Momenta, Sandoz Receive FDA Letter

The FDA sent Momenta Pharmaceuticals and Sandoz, a division of Novartis, a letter stating the abbreviated new drug application for enoxaparin sodium injection is not approvable.

Enoxaparin sodium is the generic version of sanofi-aventis’ Lovenox, a treatment for blood clots.

The letter said the application was not approvable because it does not address adequately the potential for immunogenicity of the drug product. The agency recommended the companies meet with the Office of Generic Drugs to determine what information should be provided, Momenta said.