The U.S Food and Drug Administration has announced that it has issued tentative approval for a generic version of Viread (tenofovir disoproxil fumarate). Viread is a drug that is used in combination with other antriretroviral agents in the treamtent of HIV.
"Tentative approval" means that the product meets all FDA manufacturing standards and safety and efficacy requirements but that existing patents or marketing exclusivity prevents final approval in the U.S at this time.
“The fight to save lives with high-quality anti-retroviral treatment is of significant importance to FDA,” said Gary Buehler, director of FDA’s Office of Generic Drugs. “Our scientists have been working diligently to make safe and effective treatments for AIDS available as quickly as possible to combat this worldwide problem.”
Viread by Gilead Sciences was first approved by the FDA in 2001 and belongs to a class of drugs known as Nucleotide Reverse Transriptase Inhibitors (NtRTI). The body coverts Viread into a chemical that prevents HIV from reproducing in uninfected cells. It does not, however, have any effect on cells that are already infected.
[Source: FDA]
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