AEGiS-FDA: Tentative approval of generic abacavir tablets 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


Tentative approval of generic abacavir tablets

Food and Drug Administration - May 22, 2006

The Food and Drug Administration (FDA) granted, on May 18, 2006, tentative approval for a generic version of abacavir sulfate tablets, 300 mg, manufactured by Aurobindo Pharma LTD. of Hyderabad, India. Abacavir sulfate tablets are the first generic version of the already approved Ziagen Tablets, an anti-HIV medication manufactured by GlaxoSmithKline. Tentative approval makes this product available for consideration for purchase under the President's Emergency Plan for AIDS Relief (PEPFAR).

Abacavir is a non-nucleoside reverse transcriptase inhibitor (NRTI), a class of drugs that helps keep the AIDS virus from reproducing. It is used in combination with other antiretroviral agents for the treatment of HIV-1 infection.

The agency's tentative approval means that Aurobindo's product meets all of FDA's manufacturing quality and clinical safety and efficacy standards, but existing patents and/or exclusivity prevent its marketing in the United States at this time.

Richard Klein, HIV/AIDS Program Director

Office of Special Health Issues, Food and Drug Administration
060522
FD060503

SOURCE: Food and Drug Administration (FDA).

AEGiS is a 501(c)3, not-for-profit, tax-exempt, educational corporation. AEGiS is made possible through unrestricted funding from Broadway Cares/Equity Fights AIDS, the Elton John AIDS Foundation, 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Always watch for outdated information.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. .