FDA Releases Guidance on Low Molecular Weight Heparin

On Feb. 18, 2016, FDA issued guidance discussing immunogenicity-related considerations for low molecular weight heparin (LMWH) products. The guidance also finalizes the April 2014 draft guidance Immunogenicity-Related Considerations for the Approval of Low Molecular Weight Heparin for NDAs and ANDAs.

Included in the guidance are recommendations on meeting the requirement for active ingredient sameness for abbreviated new drug applications (ANDAs) for LMWHs. FDA recommendations for addressing impurities and their effect on immunogenicity in regards to ANDAs, new drug applications (NDAs), and supplemental NDAs are also discussed in the guidance.  FDA states that drug master file (DMF) holders should be aware of the requirements and “ensure DMFs are current. DMF holders must notify authorized applicants of changes.”