FDA Approves NORVIR Oral Solution Label

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FDA HIV Email Updates provide information about FDA HIV product approval, safety warnings, medical product labeling changes, notices of upcoming meetings, and notices about proposed regulatory guidances.

The NORVIR (ritonavir) Oral Solution package insert was recently updated with the types of feeding tubes that are compatible for use.

The DOSAGE AND ADMISTRATION section was updated as follows:
 
Administering Oral Solution by Feeding Tube
 
Because NORVIR oral solution contains ethanol and propylene glycol, it is not recommended for use with polyurethane feeding tubes due to potential incompatibility. Feeding tubes that are compatible with ethanol and propylene glycol, such as silicone and polyvinyl chloride (PVC) feeding tubes, can be used for administration of NORVIR oral solution. Follow instructions for use of the feeding tube to administer the medicine

 

The updated label will soon be available at drugs@fda or DailyMed

Steve Morin

Office of Health and Constituent Affairs
Food and Drug Administration

KImberly Struble
Division of Antiviral Products
Food and Drug Administration

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