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FDA approves generic stavudine
On Jan. 5, 2009, the Food and Drug Administration (FDA) granted approval for generic stavudine capsules, USP, 30 mg and 40 mg, manufactured by Matrix Laboratories, Limited, Hyberdad, India. The application was originally reviewed under expedited review provisions for the President's Emergency Plan for AIDS Relief (PEPFAR) and granted tentative approval in April, 2007.
This full approval means that this generic formulation can be marketed in the US, as well as available for purchase by PEPFAR, because the patent protection has expired. Effective patent dates for approved drugs can be found in the agency's publication titled Approved Drug Products with Therapeutic Equivalence Evaluations, also known as the "Orange Book."
This is a generic formulation of Zerit brand capsules, 30 mg and 40 mg, made by Bristol Myers Squibb.
Stavudine is a Nucleoside Reverse Transcriptase Inhibitors (NRTI) indicated for used in combination with other antiretroviral agents in the treatment of HIV infection.
Efavirenz 100 mg scored tablets approved for pediatric treatment
On Dec. 12, 2008, the FDA granted tentative approval for efavirenz 100 mg scored tablets, indicated in combination with other antiretrovirals for the treatment of HIV-1 infection, facilitating pediatric treatment. The product is manufactured by Aurobindo Pharma Limited, Hyberdad, India.
Efavirenz is an antiviral agent in the Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI) class.
Tentative approval does make the product eligible for purchase outside the United States under the President's Emergency Plan for AIDS Relief (PEPFAR).
The application was reviewed under expedited review provisions developed by FDA for the PEPFAR program.
This tentative approval is a generic version of Sustiva, which is a product of Bristol Myers-Squibb, and 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, the 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.
A list of all Approved and Tentatively Approved Antiretrovirals in Association with the President's Emergency Plan is available on the FDA website.