Important note: Information in this article was accurate in 2006. The state of the art may have changed since the publication date.
Food and Drug Administration - December 21, 2006
This is a generic version of the already-approved Sustiva Capsules, 50 mg, 100 mg, and 200 mg, manufactured by Bristol Myers Squibb Co.
Efavirenz is a member of the class of drugs known as nonnucleoside reverse transcriptase inhibitors (NNRTIs), which help keep the AIDS virus from reproducing. This antiretroviral drug is intended to be used in combination with other antiretroviral agents for the treatment of HIV-1 infection.
The application was reviewed under expedited review provisions for the President's Emergency Plan for AIDS Relief (PEPFAR).
"Tentative Approval" means that FDA has concluded that a drug product has met all required quality, safety and efficacy standards, though it may not yet be marketed in the U.S. because of existing patents and/or exclusivity rights. This tentative approval, however, does make the product eligible for consideration for purchase under the PEPFAR program.
Richard Klein | Office of Special Health Issues | Food and Drug Administration
Kimberly Struble | Division of Antiviral Drug Products | Food and Drug Administration
061221
FD061204
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Always watch for outdated information.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. .