The US Food and Drug Administration (FDA) within the US Department of Health and Human Services (HHS) announced the tentative approval of the generic version of Abacavir Sulfate (a bak' a vir) oral solution, 20 mg (base)/mL manufactured by Hyderabad based Aurobindo Pharma Ltd.
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 paediatric formulation is indicated for use in paediatric 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.
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. 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 US, it meets all of FDA's quality, safety and efficacy standards for US marketing.
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.