<p><strong>Pregnancy</strong>: The limited available data with Delafloxacin use in pregnant women are insufficient to inform a drug-associated risk of major birth defects and miscarriages. When delafloxacin (as the N-methyl glucamine salt) was administered orally to rats during the period of organogenesis, no malformations or fetal death were observed at up to 7 times the estimated clinical exposure based on AUC. When rats were dosed intravenously in late pregnancy and through lactation, there were no adverse effects on offspring at exposures approximating the clinical intravenous (IV) exposure based on AUC.<br />
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<strong>Lactation</strong>: There are no data available on the presence of delafloxacin in human milk, the effects on the breast-fed infant, or the effects on milk production. Delafloxacin is excreted in the breast milk of rats. The developmental and health benefits of breastfeeding should be considered along with the mother&rsquo;s clinical need for Delafloxacin and any potential adverse effects on the breast-fed child from Delafloxacin or from the underlying maternal condition.</p>