Determination That PITRESSIN TANNATE IN OIL (Vasopressin Tannate) Injection, 5 Pressor Units/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness

الملخص

The Food and Drug Administration (FDA) has determined that PITRESSIN TANNATE IN OIL (vasopressin tannate) Injection, 5 pressor units/milliliter (mL), was not withdrawn from sale for reasons of safety or effectiveness.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 vasopressin tannate injection, 5 pressor units/mL, if all other legal and regulatory requirements are met.