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news.Boehringer Ingelheim Pharmaceuticals has announced that the FDA has granted approval for Aptivus capsules/oral solution with dosing information for treatment-experienced pediatric patients between the ages of 2-18 infected with HIV-1.
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The oral solution formulation, which is a new dosage form of Aptivus, was also approved for treatment-experienced adults. The oral solution formulation will be available in the US beginning in mid-September 2008. The FDA granted full approval to Aptivus capsules for treatment-experienced adults in October 2007.
Boehringer Ingelheim’s Aptivus, a protease inhibitor co-administered with ritonavir (Aptivus/r), is indicated for combination antiretroviral treatment of HIV-1 infected patients who are treatment-experienced and infected with HIV-1 strains resistant to more than one protease inhibitor.
Juan Salazar, associate professor in pediatrics for department of pediatrics and division of pediatric infectious diseases at University of Connecticut, said: “This approval is an important development for treatment-experienced children and teenagers who may have limited therapeutic options.”