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New Aptivus(R) (tipranavir) Oral Solution Approved for Treatment-Experienced Pediatric and Adolescent HIV Patients
Date:6/24/2008

APTIVUS Oral Solution Also Approved for Treatment-Experienced Adult

Patients

RIDGEFIELD, Conn., June 24 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) granted approval of Aptivus(R) (tipranavir) capsules/oral solution with dosing information for treatment-experienced pediatric patients between the ages of 2-18 infected with HIV-1. 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 U.S. beginning in mid-September. The FDA granted full (traditional) approval to APTIVUS capsules for treatment-experienced adults in October 2007.

"Due to significant advances in HIV therapy and care, many perinatally infected children are growing into young adulthood and beyond. Most of these children have received multiple courses of anti-HIV medications and many have evidence that their HIV strains have developed resistance to the majority of currently approved antiretrovirals. An unmet need remains for pediatric indications and new formulations of antiretroviral therapies," said Dr. Juan Salazar, Associate Professor in Pediatrics, University of Connecticut's Department of Pediatrics, Division of Pediatric Infectious Diseases, and Director of the Pediatric and Youth HIV Program at the Connecticut Children's Medical Center. "This approval is an important development for treatment-experienced children and teenagers who may have limited therapeutic options."

APTIVUS Indications and Usage

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.

This indication is based on analyses of plasma HIV-1 RNA levels in t
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SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.
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