WASHINGTON, July 6 -- Food and Drug Administration has issued a notice called: Determination That VASOPRESSIN IN SODIUM CHLORIDE (vasopressin) 0.9%, Injection, 50 units/50 milliliters (1 unit/milliliters) Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness.
The notice was published in the Federal Register on July 6 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.
Summary: The Food and Drug Administration (FDA or Agency) has determined that VASOPRESSIN IN SODIUM CHLORIDE (vasopressin) 0.9%, injection, 50 units/50 milliliters (mL) (1 unit/mL) was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applicati...