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# Guidance on Low Molecular Weight Heparin Immunogenicity
- URL: https://www.fdaweb.com/guidance-on-low-molecular-weight-heparin-immunogenicity/
- Published: 2016-02-18T12:00:00.000Z
- Updated: 2026-09-15T02:37:05.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5134812

> FDA has posted a [guidance](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM392194.pdf?ref=fdaweb.com) on “Immunogenicity-Related Considerations for Low Molecular Weight Heparin (LMWH)” that provides recommendations on meeting the requirement for active ingredient sameness for ANDA for LMWHs. It includes recommendations on addressing impurities and their potential effect on immunogenicity for such ANDAs. Additionally, it includes recommendations on impurities for NDAs and supplemental NDAs/ANDAs in instances where the source material or another component is changed, or when there are alterations in the manufacturing process.