Navidea Biopharmaceuticals attributed the Complete Response Letter from the US Food and Drug Administration regarding its NDA for Lymphoseek to issues with third-party contract manufacturers. In November 2009, Navidea appointed Reliable Biopharmaceutical Corporation for the manufacture and supply of the API for Lymphoseek. Final product manufacturing including final drug formulation, lyophilization and packaging processes for Lymphoseek is performed by OSO BioPharmaceuticals Manufacturing LLC.
Reuters
Tuesday 11 September 2012
Navidea blames manufacturer
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