Federal Register #2026-20442

FDA regulatory determination on pralidoxime chloride autoinjector solution

The FDA issued a regulatory determination concerning pralidoxime chloride autoinjector solution, rather than a government procurement notice. - Government agency: U.S. Department of Health and Human Services, Food and Drug Administration (FDA). - Product covered: Pralidoxime chloride autoinjector solution, 600 mg/2 mL (300 mg/mL). No purchase quantity or part number is specified. - FDA determination: The product was not withdrawn from sale for reasons of safety or effectiveness. The FDA may approve abbreviated new drug applications (ANDAs) that reference the product, subject to all other applicable requirements. - Organizations named: Meridian Medical Technologies, Inc. is identified as the holder of the product’s new drug application; Premier Research International, LLC submitted the citizen petition that prompted the determination. - Procurement status: This is not a request to buy products or services, and no contract value, performance period, or deliverable quantities are provided.

Description

The FDA determined that pralidoxime chloride autoinjector solution, 600 mg/2 mL (300 mg/mL), was not withdrawn from sale for reasons of safety or effectiveness. The product is listed in the Orange Book’s Discontinued Drug Product List, and the FDA will continue to list it there. This determination allows FDA to approve abbreviated new drug applications (ANDAs) that refer to the product, provided all other legal and regulatory requirements are met.

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