Zdrowie i gospodarka · 29.05.2014
Determination That SODIUM PERTECHNETATE TC-99M (Technetium Tc-99m Sodium Pertechnetate) Injection, Oral, 2 to 100 Millicuries per Milliliter and 10 to 60 Millicuries per Milliliter, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) has determined that SODIUM PERTECHNETATE TC-99M (technetium Tc-99m sodium pertechnetate) Injection, Oral, 2 to 100 millicuries per milliliter (mCi/mL) and 10 to 60 mCi/mL, were not withdrawn from sale for reasons of safety or effectiveness.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 sodium pertechnetate, injection, oral, 2 to 100 mCi/mL and 10 to 60 mCi/mL, if all other legal and regulatory requirements are met.