Federal Register #2026-06314

FDA Regulatory Determination on INAPSINE (Droperidol) Injection

This notice from the Food and Drug Administration (FDA) addresses the regulatory status of INAPSINE (droperidol) injection, 2.5 mg/mL: - Government Buyer: - Food and Drug Administration (FDA), Department of Health and Human Services - OEMs and Vendors: - Akorn, Inc. (original NDA holder for INAPSINE) - Products/Services: - INAPSINE (droperidol) injection, 2.5 mg/mL - No procurement of products or services is requested - Notable Requirements: - FDA determined INAPSINE was not withdrawn for safety or effectiveness reasons - Supports continued approval of generic drug applications referencing INAPSINE - No purchase quantities, part numbers, or procurement actions involved - Location: - FDA headquarters in Silver Spring, MD

Description

The Food and Drug Administration (FDA) has determined that INAPSINE (droperidol) injection, 2.5 mg/mL, was not withdrawn from sale for reasons of safety or effectiveness. This determination means the FDA will not initiate procedures to withdraw approval of abbreviated new drug applications (ANDAs) referring to this drug product. The FDA will continue to approve ANDAs for this product as long as they meet relevant legal and regulatory requirements. The notice clarifies the regulatory status of INAPSINE and supports continued generic drug approvals.

View original listing