Indian Generic Tenofovir (Viread) is approved by US FDA

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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