💊FDA Determination on Epinephrine Supports Generic Drug Approvals
Determination That EPINEPHRINE (Epinephrine) Solution, 1 Milligram/Milliliter, Prefilled Syringe for Intravenous Use, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Summary
The Food and Drug Administration (FDA or Agency) has determined that EPINEPHRINE (epinephrine) solution, 1 milligram (mg)/ milliliter (mL), prefilled syringe for intravenous use, was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The FDA's determination allows for the continuation and approval of abbreviated new drug applications (ANDAs) for epinephrine, which is critical for pharmaceutical companies looking to market generic versions. This is relevant for business owners in the pharmaceutical sector, particularly companies associated with generic drug manufacturing.