Guest guest Posted December 20, 2007 Report Share Posted December 20, 2007 Generic Tenofovir (Viread) Approved By , North American Correspondent ROCKVILLE, Md., Dec. 19 -- The FDA has granted what is called tentative approval to a generic form of tenofovir (Viread). The approval means that generic tenofovir tablets, made by Matrix Laboratories, of Andhra Pradesh, India, can be purchased and distributed overseas by the President's Emergency Plan for AIDS Relief (PEPFAR). Tenofovir joins more than 50 other drug and drug combinations granted approval under the program, which is intended to make inexpensive -- but high-quality -- versions of patented drugs available to the developing world. At the end of November, PEPFAR said it is supporting antiretroviral treatment for about 1.45 million people worldwide, most of them in 15 " focus countries, " including Botswana, Ethiopia, and South Vietnam. The approval is dubbed " tentative " because -- as long as the branded product has patent protection -- the generics are not allowed to be sold in the U.S. In essence, the designation means that the FDA has checked to see that the generics meet the same scientific and quality standards as the brand-name products that can be marketed in the U.S. The agency started the tentative approval program in 2004 to ensure that generic anti-HIV drugs could be rapidly reviewed, their quality assessed, and their acceptability for purchase with PEPFAR funds supported. At the time, counterfeit and substandard drugs were being widely sold in the countries served by PEPFAR -- a situation that was dangerous not only because the drugs were ineffective but also because they might make the pandemic worse by initiating drug resistance. In the case of tenofovir, the FDA said, the elapsed time from application to tentative approval was less than six months. Generics approved by the FDA under the program include individual drugs, such as tenofovir and abacavir (Ziagen), fixed-dose combinations that include three drugs in a single tablet, and co- packaged combinations that include medications usually used together in a single pack to promote ease of use. Tenofovir is a nucleotide reverse transcriptase inhibitor (nRTI), which prevents HIV from inserting its genetic material in a host cell's DNA. It is similar in action to the more common nucleoside reverse transcriptase inhibitors (NRTIs), such as abacavir. The difference is that the NRTIs must be activated within the cell by phosphorylation in order to function, while tenofovir -- the only approved nRTI -- can skip that step. http://www.medpagetoday.com/HIVAIDS/HIVAIDS/tb/7752 Quote Link to comment Share on other sites More sharing options...
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