Food and Drug AdministrationImportant note: Information in this article was accurate in 2006. The state of the art may have changed since the publication date.
Click here to return to FDA main menu
DonateNow
Print this Article


Generic zidovudine in Capsule Form

Food and Drug Administration - March 31, 2006
Richard Klein

This message corrects the previous (3/29/2006) notice of a tentative approval for the capsule dosage form of zidovudine to treat HIV/AIDS. While the generic formulation does qualify for consideration under the President's Emergency Fund for AIDS Relief (PEPFAR), because patents on the original formulations have expired, FDA has issued an approval for generic zidovudine capsules 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. The 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.

Zidovudine is in the class of drugs called nucleoside reverse transcriptase inhibitors (NRTIs), which help 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.

Richard Klein
HIV/AIDS Program Director
Office of Special Health Issues
Food and Drug Administration


060331
FD060305

SOURCE: Food and Drug Administration (FDA).

AEGiS is made possible through unrestricted grants from Boehringer Ingelheim, Bridgestone/Firestone Charitable Trust, Bristol-Myers Squibb Company, Elton John AIDS Foundation, the National Library of Medicine, and donations from users like you. Always watch for outdated information. This article first appeared in 2006. This material is designed to support, not replace, the relationship that exists between you and your doctor.

AEGiS presents published material, reprinted with permission and neither endorses nor opposes any material. All information contained on this website, including information relating to health conditions, products, and treatments, is for informational purposes only. It is often presented in summary or aggregate form. It is not meant to be a substitute for the advice provided by your own physician or other medical professionals. Always discuss treatment options with a doctor who specializes in treating HIV.

Copyright ©1980, 2006. AEGiS. All materials appearing on AEGiS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of AEGiS, or the party credited as the provider of the content. .