FDA Confirms Droperidol (INAPSINE) Injection 2.5 mg/mL Was Not Withdrawn for Safety or Effectiveness Reasons
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The U.S. Food and Drug Administration (FDA) has formally determined that INAPSINE (droperidol) injection at a concentration of 2.5 milligrams per milliliter was not withdrawn from the commercial market for reasons related to its safety or effectiveness. This is a regulatory classification with significant downstream consequences for generic drug approvals. Under U.S. drug law, if a brand-name drug is withdrawn from sale for safety or effectiveness reasons, generic manufacturers referencing that product cannot obtain or maintain FDA approval for their own versions. By issuing this determination, FDA clarifies that droperidol's absence from or limited presence in the market was due to commercial or business reasons—not because the drug was found unsafe or ineffective. As a direct result, FDA will not initiate withdrawal proceedings against any existing Abbreviated New Drug Applications (ANDAs) that reference INAPSINE 2.5 mg/mL. Additionally, FDA will continue to review and approve new ANDAs referencing this product, provided applicants meet all applicable legal and regulatory standards. Droperidol is an antipsychotic and antiemetic agent historically used in anesthesia and to treat nausea and vomiting. This determination reopens the regulatory pathway for generic manufacturers to bring droperidol injection products to market.
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Key Changes
- FDA formally declares INAPSINE (droperidol) injection 2.5 mg/mL was not withdrawn from sale for safety or effectiveness reasons as of April 1, 2026
- FDA will not initiate withdrawal proceedings against existing ANDAs that reference INAPSINE 2.5 mg/mL
- FDA will continue to accept and approve new Abbreviated New Drug Applications (ANDAs) referencing droperidol 2.5 mg/mL injection
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Obligations
What this law requires
Generic manufacturers may submit Abbreviated New Drug Applications (ANDAs) referencing INAPSINE (droperidol) injection 2.5 mg/mL without risk of FDA withdrawal proceedings based on safety or effectiveness concerns
ANDA applicants referencing INAPSINE 2.5 mg/mL must continue to meet all applicable legal and regulatory requirements for drug approval
FDA will not initiate withdrawal proceedings against existing Abbreviated New Drug Applications (ANDAs) that reference INAPSINE 2.5 mg/mL based on this determination
FDA will continue to review and approve new ANDAs referencing INAPSINE 2.5 mg/mL, provided applicants meet all applicable legal and regulatory standards