Determination That SODIUM FLUORIDE F 18 (Sodium Fluoride F-18) Injection, 10 to 200 Millicuries per Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness

الملخص

The Food and Drug Administration (FDA) has determined that SODIUM FLUORIDE F 18 (sodium fluoride F-18) injection, 10 to 200 millicuries per milliliter (mCi/mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for SODIUM FLUORIDE F 18 injection, 10 to 200 mCi/mL, if all other legal and regulatory requirements are met.