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FDA Tentatively Approves Generic Pediatric AIDS Drug

First generic version of abacavir sulfate can now be used outside United States

WEDNESDAY, June 28 (HealthDay News) -- The U.S Food and Drug Administration has tentatively approved the first generic version of abacavir sulfate oral solution, for use in HIV-infected pediatric patients from 3 months to 13 years.

The drug is manufactured by Aurobindo Pharma LTD in Hyderabad, India, in a 20 mg (base)/mL dose. The FDA's tentative approval means that while the drug under the Ziagen Oral Solution brand from GlaxoSmithKline is still patent-protected within the United States, the Aurobindo version can be purchased and used 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 of the 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."

Abacavir is a nucleotide reverse transcriptase inhibitor and is used to treat HIV-1 infection in combination with other antiretroviral drugs. However, at least 5 percent of patients treated with abacavir suffer from a potentially fatal hypersensitivity with symptoms including skin rash, nausea, fever and severe tiredness.

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