Zdrowie i gospodarka · 11.06.2018
Determination That MUTAMYCIN (Mitomycin) Injectable, 5 Milligrams/Vial and 20 Milligrams/Vial, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA or Agency) has determined that MUTAMYCIN (mitomycin) injectable, 5 milligrams (mg)/ vial and 20 mg/vial, was not withdrawn from sale for reasons of safety or effectiveness.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 MUTAMYCIN (mitomycin) injectable, 5 mg/vial and 20 mg/vial, if all other legal and regulatory requirements are met.