Important note: Information in this article was accurate in 2009. The state of the art may have changed since the publication date.
 |
Food and Drug Administration - July 16, 2009
Richard Klein & Kimberly Struble
On July 15, 2009, FDA granted tentative approval to a fixed-dose combination tablet containing abacavir sulfate, lamivudine and zidovudine Tablets,300 mg/150 mg/300 mg, manufactured by Matrix Laboratories Limited of Hyberdad, India, indcated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults. Fixed dose combination tablets significantly reduce pill burden and may help to improve adherence to drug regimens containing these products.
Tentative approval means that FDA has concluded that a drug product has met all of the required quality, safety and efficacy standards, but that it may not be marketed in the U.S. due to existing patents rights. However, tentative approval makes the product eligible to be considered for purchase under the President's Emergency Plan for AIDS Relief (PEPFAR) program. Existing patent information is available in the FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.
FDA conducts an on-site inspection of each manufacturing facility and of the facilities performing the bioequivalence studies prior to granting approval or tentative approval of these applications to evaluate the ability of the manufacturer to produce a quality product and to assess the quality of the bioequivalence data supporting the application.
A list of all Approved and Tentatively Approved Antiretrovirals in Association with the President's Emergency Plan can be found on the FDA website.
The abacavir sulfate/lamivudine/zidovudine fixed dose combination tablets are a version of the FDA approved Trizivir Tablets, 300 mg/150 mg/300 mg, manufactured by GlaxoSmithKline.
Richard Klein
Office of Special Health Issues
Food and Drug Administration
Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration
090716
FD090702
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 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Always watch for outdated information.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 2009. 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, 2009. 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. .