Epinephrine Syringes Deemed Safe for Continued Sale
Published Date: 6/2/2025
Notice
Summary
The FDA says epinephrine prefilled syringes for IV use weren’t pulled from the market because of safety or effectiveness problems. This means drug makers can keep getting approval to sell similar versions, so patients and healthcare providers won’t face shortages. No changes in cost or timing are expected, just smooth sailing ahead for this important medicine.
Analyzed Economic Effects
2 provisions identified: 2 benefits, 0 costs, 0 mixed.
Epinephrine IV Syringe Remains Approved
The FDA determined that EPINEPHRINE (epinephrine) solution, 1 mg/mL, prefilled syringe for intravenous use was not withdrawn from sale for reasons of safety or effectiveness. Because of that, the FDA will not start procedures to withdraw approvals of abbreviated new drug applications (ANDAs) that refer to this product, which helps keep patient access stable.
Generic Applicants Can Keep Seeking Approval
The FDA said it will continue to approve ANDAs that refer to EPINEPHRINE 1 mg/mL prefilled syringe for IV use as long as applicants meet legal and regulatory requirements. That means drug makers can keep applying for approval of generic versions that rely on this product.
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