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Johnson & Johnson's Hepatitis C Drug Gets Positive FDA Review-Reuters


Tuesday, 22 Oct 2013 11:42am EDT 

Reuters reported that a new hepatitis C drug made by Johnson & Johnson showed an acceptable safety profile in clinical trials, reviewers for the U.S. Food and Drug Administration said on October 22, 2013. The drug, simeprevir, was tested in combination with standard hepatitis C drugs, peginterferon-alpha and ribavirin, in adult patients who had failed previous interferon-based therapy or had not received medication at all. The safety signal identified in the review of the drug involved rash and/or photosensitivity and the FDA reviewers said they plan to include a related warning in the drug's label. The reviewers said that the drug would be categorized as a Pregnancy Category C in labeling, which means that the potential benefits of the drug may warrant its use in pregnant women, even though animal trials showed the drug had some adverse effects on a fetus. 

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