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Abbott's Kaletra(R) and Aluvia(R) (lopinavir/ritonavir) New Lower-Strength Tablet for Pediatric Use Receives Positive Opinion from EMEA
Date:1/28/2008

n Kampala to write the first prescription for the lower-strength tablet just days after the product received marketing authorization in the United States. Other African governments are now also talking to Abbott about the possibility of waiver shipments. According to UNAIDS, an estimated 110,000 Ugandan children were living with HIV in 2005.

The WHO recommends lopinavir/ritonavir as the preferred treatment for children who no longer respond to first-line HIV medicine. The U.S. Department of Health and Human Service recommends lopinavir/ritonavir for the initial treatment of children with HIV.

Kaletra Lower-Strength Tablets

The new tablet formulation will complement Kaletra oral solution, which has been available for pediatric use since its approval in September 2000 in the United States. For pediatric patients, lower-strength Kaletra tablets will offer more dosing flexibility and contains 100mg of lopinavir and 25mg of ritonavir, compared with the original tablet strength of 200mg of lopinavir and 50mg of ritonavir, most commonly used by adults.

"Abbott has kept the needs of children living in the developing world firmly in mind when making decisions about the development, manufacturing and delivery of our innovative product," said Scott Brun, M.D., divisional vice president, infectious diseases, Global Pharmaceutical Research and Development, Abbott. "We have been addressing the growing epidemic of HIV in children for more than a decade and will continue to for years to come."

Abbott's Commitment to Fighting HIV/AIDS

HIV/AIDS is a global problem that demands shared commitment and shared responsibility. Abbott is committed to working with governments, multilateral organizations, nongovernmental organizations (NGOs) and civil society to expand access to HIV/AIDS treatments around the world. Abbott has also made significant investments in expanding manufacturing capacity to meet the growing demand for HIV treatment in developi
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1. Abbott Receives U.S. Food and Drug Administration Approval for New Lower-Strength Kaletra(R) (lopinavir/ritonavir) Tablet for Pediatric HIV Patients
2. Ugandan Children Are Among the First to Receive Abbotts Lower-Strength Aluvia (lopinavir/ritonavir) Tablet
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