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Home » FDA Calls for More Immunogenicity Data for Generic Lovenox
FDA Calls for More Immunogenicity Data for Generic Lovenox
November 13, 2007
The FDA has issued a not-approvable letter in response to Sandoz and Momenta Pharmaceutical’s abbreviated new drug application (ANDA) for generic Lovenox, saying it does not adequately address the potential for immunogenicity of the anticoagulant.