FDA gives tentative approval to Indian AIDS drug

U.S. health officials granted tentative approval for a generic liquid version of the AIDS drug AZT, Thursday, allowing it to be used overseas under a U.S. program to fight the deadly virus.

The generic oral version of GlaxoSmithKline Plc's drug zidovudine, made by India-based drugmaker Aurobindo Pharma Ltd., is the latest in a string of approvals for the program.

However, the generic drug will not be available in the United States because of patent protections.

Glaxo sells its drug under the name Retrovir, or AZT. The nucleoside reverse transcriptase inhibitor helps keep the AIDS virus from multiplying, informs Reuters.

The US FDA has already granted a tentative approval to a generic combination drug product manufactured by the company consisting of Lamivudine 150 mg and Zidovudine 300 mg. "... [ellipsis as carried] FDA is delighted to help to ensure that HIV/AIDS products available to children through president's emergency programme are safe and effective," the FDA website quoted Deputy Commissioner for International and Special Programmes Dr Murray M. Lumpkin as having said.

The emergency plan for AIDS, launched by the President George W. Bush in 2003 for five years, is currently providing a 15bn USD [US dollars] aid to fight the dreaded disease in the hardest-hit countries, the website said.

The plan is designed to prevent million new HIV infections, treat at least 2m HIV-infected people and care for 10m HIV-affected individuals and children affected with the virus, it said. FDA's tentative approval means the drug meets safety, efficacy and quality standards of FDA. The generic drug, however, will not be available in the United States because of the strict patent regime, reports Indian Daily.

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