Label Changes for:

Divigel (estradiol gel)

May 2012

Changes have been made to the CONTRAINDICATIONS, WARNINGS and PRECAUTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – May 2012

 

 

4 CONTRAINDICATIONS

  • anaphylactic reaction or angioedema
  • thrombophilic disorders

5 WARNINGS AND PRECAUTIONS

5.15 Hereditary Angioedema ...... section added
 

 

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