BN Business News
Add your company to Business Communicator →

Zdrowie i gospodarka · 14.03.2022

Determination That MPI DMSA KIDNEY REAGENT (Technetium Tc-99m Succimer Kit), Injectable, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness

The Food and Drug Administration (FDA, Agency, or we) has determined that MPI DMSA KIDNEY REAGENT (Technetium Tc-99m Succimer Kit), Injectable, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for Technetium Tc-99m Succimer Kit, Injectable, if all other legal and regulatory requirements are met.

Source: Federal Register — Food and Drug AdministrationOpen original release →