💊FDA Determines Heparin Sodium Products Not Withdrawn for Safety
The Food and Drug Administration (FDA or Agency) has determined that HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER (heparin sodium) injectable, 5,000 units/100 milliliters (mL); HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER (heparin sodium) injectable, 5,000 units/100 mL; HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER (heparin sodium) injectable, 10,000 units/100 mL; and HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (heparin sodium) injectable, 5,000 units/100 mL under new drug application (NDA) 019802 were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) that refer to these products if all other legal and regulatory requirements are met.
Learn More💊FDA Notice on Heparin Sodium and Business Implications
The Food and Drug Administration (FDA or Agency) has determined that HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (heparin sodium) injectable, 200 units/100 milliliters (mL); HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (heparin sodium) injectable, 200 units/100 mL; and HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (heparin sodium) injectable, 1,000 units/100 mL under new drug application (NDA) 019042 were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) that refer to these products if all other legal and regulatory requirements are met.
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