Important note: Information in this article was accurate in 2009. The state of the art may have changed since the publication date.
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Food and Drug Administration - November 25, 2009
On November 24, 2009, the Food and Drug Administration granted tentative approval for generic efavirenz tablets, 50 mg, 100 mg, and 200 mg under expedited review procedures for the President's Emergency Plan for AIDS Relief (PEPFAR).
This generic formulation, made by Matrix Laboratories Limited of Hyberdad, India, is indicated in combination with other antiretrovirals for the treatment of HIV-1 infection. This tablet formulation is especially suited to pediatric treatment.
"Tentative approval" means that FDA has concluded that a drug has met all of the required quality, safety and efficacy standards, but that it cannot be marketed in the United States because of existing patent restrictions, and so cannot be granted a "full marketing approval." However, tentative approval makes the product eligible to be considered for purchase under the PEPFAR program.
Effective patent dates for all approved drugs can be found in the agency's publication titled Approved Drug Products with Therapeutic Equivalence Evaluations, also known as the "Orange Book"
FDA conducts an on-site inspection of each manufacturing facility, as well as the facilities that perform the bioequivalance studies prior to granting approval or tentative approval to evaluate the ability of the manufacturer to produce a quality product, and to assess the quality of bioequivalence data supporting the application.
Efavirenz is generic version of the Nonnucleoside Reverse Transcriptate Inhibitor (NNRTI), Sustiva, marketed by Bristol Myers-Squibb.
A list of all Approved and Tentatively Approved Antiretrovirals in Association with the President's Emergency Plan 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
091125
FD091107
SOURCE: Food and Drug Administration (FDA).
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