Important note: Information in this article was accurate in 2008. The state of the art may have changed since the publication date.
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Food and Drug Administration - January 29, 2008
Richard Klein & Kimberly Strubl
"Tentative Approval" means that FDA has concluded that a drug product has met all required quality, safety and efficacy standards, even though it is not yet eligible to be marketed in the U.S. because of existing patents and/or exclusivity rights. However, this tentative approval does make the product eligible for consideration for purchase under the President's Emergency Plan for AIDS Relief (PEPFAR) program.
This is a generic version of Epivir, manufactured by GlaxoSmithKline, which is subject to existing patent protection.
Effective patent dates can be found in the agency's 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.
Richard Klein
Office of Special Health Issues
Food and Drug Administration
Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration
080129
FD080103
SOURCE: Food and Drug Administration (FDA).
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