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FDA grants
fast-track review of Australian microbicide

FDA grants
fast-track review of Australian microbicide

The Food and Drug Administration on Tuesday granted fast-track review status to an experimental microbicide developed by Australian firm Starpharma that shows promise in preventing sexually acquired HIV infections, The Australian reports. The microbicide, called VivaGel, recently completed a Phase I safety study and is entering large-scale human trials to see how well it protects against HIV and other sexually transmitted diseases. Starpharma hopes to have the product submitted for FDA review in 2008. The FDA fast-track review status guarantees that the product will be reviewed and a decision on its approval issued within six months of submission.

Most microbicide products currently in development at pharmaceutical and biotechnology companies worldwide are being studied to gauge their ability to prevent HIV infection among sexually active women. Researchers, though, believe that microbicides may also be effective for sexually active gay men, particularly when used with condoms. (

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