FDA recaps September safety label changes, with "boxed warning" only for Arava
This article was originally published in Scrip
In its monthly update on safety label changes, the US FDA revealed that it approved just one addition of a "boxed warning" in September – Sanofi-Aventis's rheumatoid arthritis drug Arava (leflunomide). Overall, there were 37 safety label changes, but most were for the lesser concerns of additions to the "Warnings and Precautions" section, according to the agency's MedWatch review.
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