Federal Register #2026-13492

FDA Regulatory Notice: Vasopressin in Sodium Chloride 0.9% Injection Not Withdrawn for Safety or Effectiveness

This FDA notice addresses the regulatory status of Vasopressin in Sodium Chloride 0.9% injection: - Government Buyer: - Department of Health and Human Services (HHS) - Food and Drug Administration (FDA) - OEMs and Vendors Mentioned: - Long Grove Pharmaceuticals, LLC (NDA holder) - Fresenius Kabi USA, LLC (citizen petition submitter) - Products/Services Referenced: - Vasopressin in Sodium Chloride 0.9% injection, 50 units/50 mL (1 unit/mL) - NDA 217766 - Indicated for increasing blood pressure in adults with vasodilatory shock unresponsive to fluids and catecholamines - Unique/Notable Requirements: - FDA determined the product was not withdrawn for safety or effectiveness reasons - FDA may approve abbreviated new drug applications (ANDAs) for generic versions if all other requirements are met - No procurement or purchase quantities are specified - Notice does not request products or services; it is a regulatory determination

Description

The Food and Drug Administration (FDA) has determined that VASOPRESSIN IN SODIUM CHLORIDE (vasopressin) 0.9%, injection, 50 units/50 milliliters (1 unit/mL) was not withdrawn from sale for reasons of safety or effectiveness. This determination allows FDA to approve abbreviated new drug applications (ANDAs) for this product if all other legal and regulatory requirements are met. The drug is indicated to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines. The notice includes a review of the citizen petition and FDA's evaluation of relevant data and literature.

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