Important note: Information in this article was accurate in 2008. The state of the art may have changed since the publication date.
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Food and Drug Administration - June 23, 2008
Richard Klein & Kimberly Struble
On June 23, 2008, FDA approved a new Aptivus (tipranavir) oral solution (100 mg/mL). The product label has been updated to include dosing recommendations for pediatric patients 2-18 years of age.
In addition, information regarding oral and parenterally administered midazolam was updated in the Contraindication and Drug Interactions section.
Please see the attached pdf file for specific pediatric labeling information and for updated information about midazolam.
Richard Klein
Office of Special Health Issues
Food and Drug Administration
Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration
080623
FD080604
SOURCE: Food and Drug Administration (FDA).
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