Important note: Information in this article was accurate in 2008. The state of the art may have changed since the publication date.
 |
Food and Drug Administration - December 13, 2008
Richard Klein & Kimberly Struble
On December 12, 2008, FDA granted tentative approval for efavirenz 100 mg scored tablets, indicated in combination with other antiretrovirals for the treatment of HIV-1 infection, facilitating pediatric treatment. The product is manufactured by Aurobindo Pharma Limited, Hyberdad, India.
Efavirenz is an antivral agent in the Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI) class.
"Tentative approval" means that FDA has concluded that a drug product meets all required quality, safety and efficacy standards, but is not eligible for marketing in the U.S. because of existing patents and/or exclusivity rights. However, tentative approval does make the product eligible for purchase outside the United States under the President’s Emergency Plan for AIDS Relief (PEPFAR) .
The application was reviewed under expedited review provisions developed by FDA for the PEPFAR program
This tentative approval is a generic version of Sustiva, which is a product of Bristol Myers-Squibb, and is subject to existing patent protection. Effective patent dates can be found in the agency's publication titled Approved Drug Products with Therapeutic Equivalence Evaluations, also known as the "Orange Book"
As with all generic applications, FDA conducts an on-site inspection of each manufacturing facility, and of the facilities performing the bioequivalence studies, to evaluate the ability of the manufacturer to produce a quality product and to assess the quality of the bioequivalence data supporting the application prior to granting approval or tentative approval to these applications.
A list of all Approved and Tentatively Approved Antiretrovirals in Association with the President's Emergency Plan is available on the FDA website.
Richard Klein
Office of Special Health Issues
Food and Drug Administration
Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration
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 Boehringer Ingelheim, Bridgestone/Firestone Charitable Trust, Elton John AIDS Foundation UK, the National Library of Medicine, AIDS Walk of Orange County, and donations from users like you.
Always watch for outdated information. This article first appeared in 2008. 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, 2008. 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. .