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 - August 13, 2009
Richard Klein & Kimberly Struble
"Tentative approval" means that FDA has concluded that a drug product meets all required quality, safety and efficacy standards, but is not presently eligible for final approval or 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).
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.
The product is a generic formulation of Atripla Tablets, 600 mg/200 mg/300 mg of Gilead Sciences Inc., which is subject to various patent protections.
Patent information is available for this and other approved products in FDA's Approved Drug Products with Therapeutic Equivalence Evaluations(the "Orange Book"): http://www.accessdata.fda.gov/scripts/cder/ob/docs/obdetail.cfm?Appl_No=021937&TABLE1=OB_Rx
A complete list of all Approved and Tentatively Approved Antiretrovirals in Association with the President's Emergency Plan is available on the FDA web site: http://www.fda.gov/InternationalPrograms/FDABeyondOurBordersForeignOffices/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
090813
FD090807
SOURCE: Food and Drug Administration (FDA).
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