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FDA Approves First Pediatric Generic AIDS Drug for U.S. Marketing
"These approvals will now allow those infected with HIV more access to these life-saving drugs within our country. Some of these products have been available for purchase outside the U.S. as tentatively approved products under the President's Emergency Plan for Aids Relief," said Health and Human Services Secretary Mike Leavitt. "Generic products help reduce costs to patients and for the first time this antiretroviral drug will be available as a generic pediatric dosage form."
"FDA's action today shows clearly that the tentatively approved products being purchased under the President's Emergency Plan are indeed products we will make available to our own people once any U.S. market patent or exclusivity expires,” said FDA Commissioner Lester Crawford.
Zidovudine is in the class of drugs called nucleoside reverse transcriptase inhibitors (NRTIs), which help keep the AIDS virus from reproducing. This antiretroviral drug is intended to be used with other antiretroviral agents for the treatment of HIV infection.
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.
More information on HIV and AIDS is available online at FDA's website: https://www.fda.gov/ForConsumers/byAudience/ForPatientAdvocates/HIVandAIDSActivities/default.htm.
Source: The Food and Drug Administration