Label Changes for:
Malarone (atovaquone and proguanil hydrochloride) tablets
September 2009
Changes have been made to the PRECAUTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- September 2009
PRECAUTIONS
Carcinogenesis, Mutagenesis, Impairment of Fertility/Proguanil
- A fertility study in Sprague-Dawley rats revealed no adverse effects at doses...
Pregnancy
- A pre- and post-natal study in Sprague-Dawley rats revealed no adverse...
