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FDA Gives Tentative Approval for Another First Time Generic Pediatric AIDS Drug in Association with the President's Emergency Plan for AIDS Relief

Date: June 27, 2006
Source: Food and Drug Administration (FDA)

FOR IMMEDIATE RELEASE P06-87 June 27, 2006 FDA Gives Tentative Approval for Another First Time Generic Pediatric AIDS Drug in Association with the President┬┐s Emergency Plan for AIDS Relief
The Food and Drug Administration (FDA) within the U.S. Department of Health and Human Services (HHS) today announced the tentative approval of the generic version of Abacavir Sulfate (a bak' a vir) Oral Solution, 20 mg (base)/mL manufactured by Aurobindo Pharma LTD. of Hyderabad, India. The Aurobindo version of abacavir solution is the first generic version of the already approved Ziagen Oral Solution brand of abacavir manufactured by GlaxoSmithKline. This pediatric formulation is indicated for use in pediatric patients from 3 months through 13 years of age infected with HIV. Because of its tentative approval by FDA, this Aurobindo generic version of abacavir solution will now be available for consideration for purchase and use outside the United States under the President's Emergency Plan for AIDS Relief (PEPFAR). "Saving the lives of children with HIV is a foremost goal of PEPFAR," said Gary Buehler, R.Ph., Director, Office of Generic Drugs. "The agency's action today can help bring effective treatment to thousands of infected children, and thereby dramatically brighten their future." The Emergency Plan for AIDS Relief, which President Bush first announced in his 2003 State of the Union Address, is currently providing $15 billion to fight the HIV/AIDS pandemic over five years, with a special focus on 15 of the hardest hit countries. The President's Emergency Plan is designed to prevent seven million new HIV infections, treat at least two million HIV-infected people, and care for ten million HIV-affected individuals, AIDS orphans and vulnerable children. It targets three specific areas related to HIV/AIDS: Prevention of HIV transmission; Treatment of AIDS and associated conditions; Care, including palliative care for HIV infected-individuals, and care for orphans and vulnerable children. Abacavir is in the class of drugs called nucleoside reverse transcriptase inhibitors (NRTIs). NRTIs help keep the AIDS virus from reproducing. Abacavir is used in combination with other antiretroviral agents for the treatment of HIV-1 infection. A potentially fatal hypersensitivity, or allergic reaction, has been associated with the use of abacavir in at least 5 percent of patients. Symptoms of this reaction may include skin rash, fever, nausea, abdominal pain and severe tiredness. The agency's tentative approval of Aurobindo's abacavir solution means that although existing patents and/or exclusivity prevent marketing of this product in the U.S., it meets all of FDA's quality, safety and efficacy standards for U.S. marketing. More information on HIV and AIDS is available online at FDA's website:

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