Droperidol Drug Cleared for Generics, No Drama Here
Published Date: 4/1/2026
Notice
Summary
The FDA has decided that INAPSINE (droperidol) injection wasn’t taken off the market because of safety or effectiveness problems. This means generic versions can keep being approved and sold as long as they follow the rules. Patients and healthcare providers can keep trusting this medicine without worry, and drug makers can continue their work without delays or extra costs.
Analyzed Economic Effects
2 provisions identified: 1 benefits, 1 costs, 0 mixed.
Generics Stay Approvable; Market Access Preserved
The FDA determined that INAPSINE (droperidol) injection, 2.5 mg/mL (NDA 016796, initially approved June 11, 1970), was not withdrawn for reasons of safety or effectiveness. Because of that determination, FDA will not start procedures to withdraw approval of existing ANDAs that refer to this product and may continue to approve new ANDAs that rely on this listed drug as long as they meet legal and regulatory requirements.
Possible Labeling Updates for ANDA Applicants
The FDA said it may advise ANDA applicants to revise the product labeling for INAPSINE (droperidol) injection to meet current standards. If FDA determines labeling should be revised, ANDA applicants will be asked to submit updated labeling.
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