FDA Clears Path for Cheaper Heparin Generics to Hit Market
Published Date: 8/4/2025
Notice
Summary
The FDA says three types of heparin sodium injectable drugs weren’t pulled from the market because of safety or effectiveness problems. This means generic drug makers can now get approval to make and sell their versions, helping keep medicine options open and possibly prices down. Patients and healthcare providers can keep trusting these medicines without worry.
Analyzed Economic Effects
2 provisions identified: 2 benefits, 0 costs, 0 mixed.
Enables ANDA Approvals Referencing These Heparins
Because of that finding, the FDA can approve abbreviated new drug applications (ANDAs) that refer to these three heparin sodium products under NDA 019042, provided all other legal and regulatory requirements are met. That allows companies seeking generic approval to use these reference products in their ANDA submissions.
FDA Finds Three Heparin Products Intact
The FDA determined that three heparin sodium injectable products under NDA 019042 were not withdrawn from sale for reasons of safety or effectiveness. The products named include: heparin sodium 1,000 units in sodium chloride 0.9% in plastic container (injectable, 200 units/100 mL), heparin sodium 2,000 units in sodium chloride 0.9% in plastic container (injectable, 200 units/100 mL), and heparin sodium 5,000 units in sodium chloride 0.9% in plastic container (injectable, 1,000 units/100 mL).
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