Zdrowie i gospodarka · 11/04/2014

Determination That ZOVIRAX (Acyclovir Sodium) Injection, Equivalent to 250 Milligrams Base/Vial, 500 Milligrams Base/Vial, and 1 Gram Base/Vial, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness

The Food and Drug Administration (FDA) has determined that ZOVIRAX (acyclovir sodium) Injection, equivalent to (EQ) 250 milligrams (mg) base/vial, 500 mg base/vial, and 1gram (g) base/vial, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for ZOVIRAX (acyclovir sodium) Injection, EQ 250 mg base/vial, 500 mg base/vial, and 1 g base/vial, if all other legal and regulatory requirements are met.