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Label Changes for:

Mycamine (micafungin sodium) for injection

June 2011

Changes have been made to the ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – June 2011




Postmarketing Adverse Reactions
  • Skin and subcutaneous tissue disorders: Stevens-Johnson syndrome, toxic epidermal necrolysis
  • Blood and lymphatic system disorders: disseminated intravascular coagulation