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news.Momenta Pharmaceuticals and its collaboration partner, Sandoz, a division of Novartis, said that the FDA has issued a letter stating that Sandoz's abbreviated new drug application for enoxaparin sodium injection to prevent and treat deep vein thrombosis is not approvable.
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The FDA said that the abbreviated new drug application (ANDA) was not approvable because the application does not adequately address the potential for immunogenicity of the drug product and recommended that Sandoz and Momenta meet with the office of generic drugs to determine what additional information should be provided to adequately address this concern. Sandoz and Momenta are working together to identify the additional information that is necessary to obtain approval of the ANDA.
Craig Wheeler, president and CEO of Momenta, said: “In a follow-up call, the FDA clarified that all applications for enoxaparin products must address the potential for immunogenicity of the drug product. We believe that we can address what we anticipate to be the FDA’s concerns, based on our detailed characterization of enoxaparin and on the current medical and scientific literature. Our path forward will be determined in conjunction with Sandoz and the FDA.”