Zdrowie i gospodarka · 11/06/2018

FDA Clears Path for MUTAMYCIN (Mitomycin) Injectable to be Approved via Abbreviated New Drug Applications

The US Food and Drug Administration (FDA) has ruled that MUTAMYCIN (mitomycin) injectable, 5 milligrams/vial and 20 milligrams/vial, was not withdrawn from sale due to safety or effectiveness concerns, paving the way for potential approval of abbreviated new drug applications (ANDAs) for these formulations.