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UCB Cimzia Advances Pregnancy And Lactation Labeling For Biologics

 
• By Bridget Silverman

First industry-sponsored pharmacokinetic studies evaluating transfer of a biologic through placenta and breast milk support US FDA approval of new labeling describing low level of Cimzia in fetuses and infants – and highlight the pregnancy and lactation research challenges being explored by task force under 21st Century Cures Act. 

Pregnant belly

The recent approval of new pregnancy and lactation labeling for UCB Group's Cimzia (certolizumab pegol) marks an advance for the US FDA's efforts to improve advice for prescribers debating whether expectant and breastfeeding mothers can continue medication, but the amount of work entailed illustrates some of the hurdles to providing clinical data in labeling for special populations.

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