FDA Updates Tenofovir Disoproxil Fumarate (Viread) Label with New Dosing and Formulation Information

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Posted January 2012

“On January 18, 2012, the Viread (tenofovir disoproxil fumarate) labeling was updated to include dosing information in pediatric patients 2 to less than 18 years of age. An oral powder (40 mg per 1 gram of oral powder) formulation and 150 mg, 200 mg and 250 mg tablets were also approved to support dosing in pediatric patients. … In addition the patient labeling was updated to include information on pediatric patients and instruction on how to prepare and give Viread oral powder.”

The updated label will be available soon at the FDA Web site.