Canada Clarifies Generic Pathway for Low Molecular Weight Heparins

Health Canada is asking generic drugmakers seeking approval of drugs containing low molecular weight heparins (LMWH) to use the approval pathway for subsequent entry biologics. The traditional route for abbreviated new drug submissions primarily pertains to generics of small molecule drugs and may not properly ensure the efficacy and safety of LMWH products, whose biologically derived components “are not fully characterized,” the agency says.
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