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
Combination products like this one can decrease pill burden and may result in improved dosing compliance for HIV infected individuals.
FDA's tentative approval of this product means that although existing patents and/or exclusivity 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 the President's Emergency Plan for AIDS Relief (PEPFAR).
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.
The application was reviewed under expedited review provisions for PEPFAR, A list of all Approved and Tentatively Approved Antiretrovirals in Association with the President's Emergency Plan is available on the FDA website: http://www.fda.gov/InternationalPrograms/FDABeyondOurBordersForei gnOffices/AsiaandAfrica/ucm119231.htm
Richard Klein
Office of Special Health Issues
Food and Drug Administration
Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration
090716
FD090705
SOURCE: Food and Drug Administration (FDA).
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