FDA determines pralidoxime chloride AUTOINJECTOR not withdrawn for safety or effectiveness
FDA has determined that pralidoxime chloride AUTOINJECTOR solution, 600 mg/2 mL (300 mg/mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination allows FDA to approve abbreviated new drug applications for the product if other requirements are met.
Primary source
Federal Register notice, October 6, 2026
Determination PRALIDOXIME CHLORIDE (Autoinjector) (Pralidoxime Chloride) Solution, 600 Milligrams/2 Milliliters (300 Milligrams/Milliliter), Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Machine-summarized from the source above; not independently reported. How we use automation