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For Consumers

Tenative approval of efavirenz cross-scored tablets, 200 mg

On February 12, 2010, the Food and Drug Administration (FDA) granted tentative approval for efavirenz cross-scored tablets, 200 mg, manufactured by Strides Arcolab Limited of Bangalore, India.  The cross-scored tablet can be broken into two 100 mg or four 50 mg doses to facilitate pediatric dosing. 

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 proprietary issues currently prevent marketing of the product in the United States.  Tentative approval, however, does qualify the product for consideration for purchase under the PResident's Emergency Plan for AIDS Relief (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.

Efavirenz is a generic version of  Sustiva, a Nonnnucleoside Reverse Transcriptase Inhibitor (NNRTI), manufactured by Bristol Myers-Squibb.

A list of all approvals and tentative approvals under these provisions can be found at 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

Page Last Updated: 08/21/2014
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