The Priority Review

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Premier Research International

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  1. Regulation

    FDA determines pralidoxime chloride AUTOINJECTOR not withdrawn for safety or effectiveness

    FDA has determined that pralidoxime chloride AUTOINJECTOR solution, 600 mg/2 mL (300 mg/mL), was not withdrawn from sale for reasons of safety or effectiveness.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.