AIDS Generic Drugs Approved by FDA for Sale in US

by Medindia Content Team on  September 21, 2005 at 2:46 PM Drug News
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AIDS Generic Drugs Approved by FDA for Sale in US
Expiry of Patent period for branded Zidovudine in US has lead to approval of FDA for new generic version of AZT, which would cost less and can be imported from other countries.

Zidovudine (AZT), is an anti-retroviral drug used in the treatment of AIDS, the drug prevents the replication of the virus inside the humans by stopping the multiplication of the virus. The drug is also used in combination with other anti-retroviral drugs to combat HIV infection. Generic drugs of Zidovudine was not available in US market due to strict patent laws, so the people can use only branded Zidovudine drugs, as branded drugs are very costly, treatment using AZT has been very costly in the US. Due to expiry of the patents in the US for Zidovudine, now generic drugs can be sold and brought in US, though generic drugs are cheaper compared to branded drugs, some critics and pharmaceutical giants worry about the quality and safety of using the generic drugs. Now that those patents have expired, versions of drug manufactured by Roxane Laboratories of Columbus, Ohio; Ranbaxy Laboratories of Gurgaon, India, and Aurobindo Pharma of Hyderabad, India, can go on the market. The drug Retrovir which was approved in 1987, manufactured by GlaxoSmithKline and approved by FDA costs about $7 for one 300 milligram tablet.

"These approvals will now allow those infected with HIV more access to these life-saving drugs within our country," said Mike Leavitt, secretary of the Department of Health and Human Services, in a statement.

(Source: The Associated Press)

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