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 - November 20, 2009
On November 20, 2009, the Food and Drug Administration (FDA) granted tentative approval for a generic formulation of fixed dose combination lopinavir/ritonavir tablets, 200 mg/50 mg, made by Cipla Limited of Mumbai, India. This dual protease inhibitor tablet is indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults.
The application was reviewed under expedited review provisions for the President's Emergency Plan for AIDS Relief (PEPFAR). FDA's tentative approval of this product means that although existing patents prevent marketing of this product in the United States, the product has been shown to meet all of FDA's safety, efficacy, and manufacturing quality standards required for marketing in the U.S., and thus qualifies for consideration for purchase under PEPFAR .
This is a generic formulation of Kaletra, made by Abbott Laboratories, which is a dual protease inhibitor combination tablet. Effective patent date information is available in the FDA 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 prior to granting approval or tentative approval to 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 (PEPFAR) 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
091120
FD091103
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 Elton John AIDS Foundation, 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Always watch for outdated information.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. .