AEGiS-Reuters: US OKs generic AIDS drug for children's use abroad

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US OKs generic AIDS drug for children's use abroad

Reuters NewMedia - November 4, 2005


WASHINGTON (Reuters) - U.S. health regulators approved a generic liquid version of GlaxoSmithKline's AIDS drug Epivir for use under the nation's program to help fight the disease in other countries, officials said on Friday.

The Food and Drug Administration said the generic drug called lamivudine, made by India's Aurobindo Pharma Ltd., will not be available in the United States because of existing patents.

The drug is the latest in a string of tentative AIDS drug approvals this year for the U.S. program to fight the deadly disease.

U.S. President George W. Bush launched the five-year, $15 billion program in 2003 to pay for treatment for 2 million AIDS sufferers and provide care for 10 million others in 15 countries, mostly in Africa.

Lamivudine is a solution for use in children between 3 months and 16 years. It is type of nucleoside reverse transcriptase inhibitor, a class of drugs that helps keep the AIDS virus from reproducing, and is supposed to be used in combination with other antiretroviral drugs.

Shares of Glaxo were near flat at $52.54 in midday trading on the New York Stock Exchange.


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