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...
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