Pediatric Generic AIDS Drug manufactured by Aurobindo Pharma

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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:

(1) zidovudine (zye-DOE-vue-deen) tablets manufactured by Ranbaxy

Laboratories Limited of Guragon, India;

(2) zidovudine tablets and oral solution manufactured by Aurobindo

Pharma LTD. Hyderabad, India; and

(3) zidovudine tablets manufactured by Roxane Laboratories of

Columbus, Ohio, U.S.A.

These are the first generic versions of the already-approved

Retrovir brand manufactured by GlaxoKline 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.

More information on HIV and AIDS is available online at FDA's

website: http://www.fda.gov/oashi/aids/hiv.html.