Zidovudine dep atalghan Eydiz kisilining tunji kapsulluq dorisi
Amirkining yimeklik we dorilarni bashquridighan eng ali orgini FDA
ning testiqidin otup, resmi bazargha kirdi.

FDA Approves First Generic HIV/AIDS Drug in Capsule Form
for United States Market

The Food and Drug Administration (FDA), an agency of the U.S.
Department of Health and Human Services today issued the first
generic approval for the capsule dosage form of zidovudine to treat
HIV/AIDS to be marketed in the United States. The tablet and oral
solution dosage forms of zidovudine were previously approved for
sale in the United States when the patent on those dosage forms
expired in September 2005. Today¡¯s approval for the capsule
formulation of the drug, which is manufactured by Aurobindo Pharma
LTD. in Hyderabad, India, follows the expiration of GlaxoSmithKline¡¯
s patent on its capsule form of the product marketed under the
tradename Retrovir.

¡°This is a significant generic approval,¡± said Dr. Andrew C. von
Eschenbach, Acting Commissioner of Food and Drugs. ¡°Retrovir, which
was initially approved in March, 1987, was the first of a group of
breakthrough medications that have transformed what was then a
disease with a very dismal prognosis into one with a much more
hopeful prognosis. Approval of this additional dosage form of
zidovudine should help reduce the cost of this therapy for American
patients.¡±

Zidovudine is in the class of drugs called nucleoside reverse
transcriptase inhibitors (NRTIs), which helps keep the AIDS virus
from reproducing. This anti-retroviral drug is intended to be used
with other anti-retroviral agents for the treatment of HIV-1
infection.

The agency¡¯s approval of zidovudine means that there are no
existing patents and/or exclusivity preventing the approval of
generic versions of this product. As with all FDA-approved generics,
this product must meet all of FDA¡¯s manufacturing quality, and
clinical safety and effectiveness standards for U.S. marketing.

More information on HIV and AIDS is available online at FDA¡¯s
website: http://www.fda.gov/oashi/aids/hiv.html.