Important note: Information in this article was accurate in 2007. The state of the art may have changed since the publication date.
Food and Drug Administration - March 16, 2007
Richard Klein and Kimberly Struble
The first is a fixed dose combination of stavudine/lamivudine (40mg/150mg) tablets, co-packaged with nevirapine tablets (200mg) for use in HIV-1 treatment of HIV-1.
The second is a fixed dose combination of Stavudine/Lamivudine (40mg/150mg) Tablets for use in HIV-1 treatment in combination with other antiretroviral drugs.
These products represent drug combinations which can significantly decrease pill burden and could result in improved compliance for HIV infected individuals.
FDA's tentative approval means that although a product meets all of the safety, efficacy, and manufacturing quality standards required for marketing in the U.S., existing patents and/or exclusivity currently prevent marketing of the product in the United States. Tentative approval, however, qualifies the product for consideration for purchase under the PEPFAR program.
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
070316
FD070304
SOURCE: Food and Drug Administration (FDA).
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