FDA determined that vasopressin in 0.9% sodium chloride injection, 50 units/50 mL (1 unit/mL) in a single-dose ready-to-use container, was not withdrawn from sale for reasons of safety or effectiveness. The determination clears the way for FDA to approve abbreviated new drug applications (ANDAs) for generic versions of the premixed vasopressin product if all other legal and regulatory requirements are met. The notice was filed under Docket No. FDA-2026-P-0525 and opens a path to expanded generic supply of the premixed formulation used in vasodilatory shock.
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