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FDA to debate pediatric APAP dosing during mid-week advisory committee meeting
WASHINGTON — The Food and Drug Administration is convening its Nonprescription Drugs Advisory Committee Tuesday and Wednesday to debate mandating weight-based dosing for pediatric medicines containing acetaminophen on the Drug Facts label, as well as the potential expansion of dosing instructions to incorporate children under the age of 2 years old, according to material posted online by the FDA on Friday.
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Victrelis approved by FDA as chronic hepatitis C treatment
SILVER SPRING, Md.— The Food and Drug Administration has approved a new treatment for chronic hepatitis C, the agency said Friday.
The FDA announced the approval of Merck’s Victrelis (boceprevir) for patients with the disease. The drug is designed for patients who still have some liver function and have not previously received treatment for chronic hepatitis C infection or have failed previous treatments. The drug is approved for use in combination with the generic drug ribavirin and pegylated interferons, biotech drugs used for treating the disease.