Label Changes for:
Divigel (estradiol gel)
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
- anaphylactic reaction or angioedema
- thrombophilic disorders
5 WARNINGS AND PRECAUTIONS
5.15 Hereditary Angioedema ...... section added