FDA Approves First Pediatric Generic AIDS Drug for U.S. Marketing

The U.S. Food and Drug Administration (FDA) within the U.S. Department of Health and Human Services (HHS) today announced the approval for marketing of several generic versions of drugs that treat HIV, the virus that causes AIDS. Previously, the products had been only tentatively approved and were not available in the United States because patent or market exclusivity blocked their approval. With the expiration of those patents, the following products today have receive full marketing authorization for the United States: zidovudine tablets manufactured by Ranbaxy Laboratories Limited of Guragon, India; zidovudine tablets and oral solution manufactured by Aurobindo Pharma LTD. of Hyderabad, India; and zidovudine tablets manufactured by Roxane Laboratories of Columbus, Ohio. These are the first generic versions of the already-approved Retrovir brand manufactured by GlaxoSmithKline to be approved for marketing in the U.S. FDA previously determined as part of a tentative approval action that these products meet all U.S. manufacturing quality and clinical safety and efficacy standards.

"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

Source: FDA