FDA Notifications
July 1, 2008 6 minutes read
Generic emtricitabine approved by FDA
On May 9, 2008, the Food and Drug Administration (FDA) granted tentative approval for a generic formulation of emtricitabine capsules, 200 mg, manufactured by Aurobindo Pharma Limited, Hyberdad, India, for use in combination with other antiretrovirals in the treatment of HIV infection. The application was reviewed under expedited review provisions for the President's Emergency Plan for AIDS Relief (PEPFAR), and represents the first tentative approval of a generic formulation of emtricitabine.
"Tentative approval" means that FDA has concluded that a drug product has met all required quality, safety and efficacy standards, but is not eligible for marketing in the U.S. because of existing patent protections and/or exclusivity rights. Tentative approval does, however, make the product eligible for consideration for purchase outside the United States 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, 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.
This tentative approval is for a generic version of Emtriva Capsules, 200 mg, marketed by Gilead Sciences Inc., a Nucleoside Reverse Transcriptase Inhibitor (NRTI). Emtriva is subject to existing patent protections and pediatric exclusivity extensions. 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."
A list of all Approved and Tentatively Approved Antiretrovirals in Association with the President's Emergency Plan (PEPFAR) is available on the FDA website at www.fda.gov.
FDA: Tentative approval of generic nevirapine
On May 15, 2008, the FDA granted tentative approval for a generic formulation of nevirapine tablets, 200 mg, manufactured by Matrix Laboratories Limited, Hyberdad, India, for use in combination with other antiretrovirals in the treatment of HIV infection. The application was reviewed under expedited review provisions for the President's Emergency Plan for AIDS Relief (PEPFAR)
This tentative approval is a generic version of Viramune Tablets, 200 mg, a Nonnucleoside Reverse Transcriptase Inhibitor (NNRTI), which is a product of Boehringer Ingelheim Pharmaceuticals Inc.
Viramune 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, 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 (PEPFAR) is available on the FDA website.
CDC web series on HIV among blacks
The April 18, 2008, edition of the Morbidity & Mortality Weekly Report (MMWR) by the Centers for Disease Control and Prevention (CDC) in Atlanta, GA, provides this information:
Notice to Readers: Web Series: HIV/AIDS Crisis Among African Americans
The CDC and the Public Health Training Network will offer the six-part web series, A Call to Action for Leaders: The Crisis of HIV/AIDS Among African Americans, available online beginning June 30, 2008. This series is designed to 1) increase awareness of HIV/AIDS in African American communities; 2) highlight innovative, sustainable, and collaborative actions taken by leaders in places where African Americans live, work, play, learn, and worship; and 3) provide links to available resources. David Satcher, former Director of CDC and the 16th Surgeon General of the United States, will serve as senior host of the web series.
Each part of the series is a prerecorded, 30-minute segment, which can be viewed on computers with Internet access and Windows Media Player. The series will be available at http://www2a.cdc.gov/phtn. Parts 1-3 can be viewed beginning June 30, and parts 4-6 can be viewed beginning Nov. 30. A free DVD of this series can be ordered by telephone (800-458-5231) after June 30 (parts 1-3) and after November 30 (parts 1-6).
NYC reports false positives spike with oral fluid tests
CDC: Tests play important role, but confirm positives
Episodic, unexplained false positive results with an oral fluid rapid HIV test, have resulted in changed protocols in some clinics and an ongoing investigation by the Centers for Disease Control and Prevention. The test, OraQuick Advance Rapid HIV-1/2 Antibody Test (Orasure Technologies, Bethlehem, PA), can be performed on oral fluid and has broadened the settings in which HIV testing can be provided, the CDC noted.1
The New York City Department of Health and Mental Hygiene (NYC DOHMH) reported the problem, leading the CDC to underscore "the importance of routinely comparing reactive rapid test results with confirmatory Western blot test results as an essential component of quality assurance in HIV testing." Several other jurisdictions have noted clusters of false-positive oral fluid rapid HIV tests since an initial report from Minnesota in 2004, the CDC reports. "Although the causes of these clusters of false-positive tests remain unexplained, investigations are under way to determine which specific factors (e.g., test device, site, operator, or oral fluid characteristics of specific patients) might be associated with increased numbers of false-positive test results," the agency noted. "…Overall, oral fluid rapid tests have performed well and make HIV testing possible in many venues where performing phlebotomy or finger sticks is impractical for screening. However, users should be aware of the unexplained variability in the rate of false-positive test results."
The incidents resulted in NYC DOHMH opting to use the finger stick rapid test while efforts are continuing to find the cause of the increase in false positive results. The first cluster of false positive tests occurred in late 2005 and subsided after several months. Another, larger increase in the incidence of false-positive oral fluid rapid test results began in late 2007 and continued through April 2008, at which time the NYC DOHMH discontinued offering this test in its STD clinics. From November 2007 to April 2008 the number of false-positive test results exceeded the number that would have been expected based on the upper limit of the manufacturer's claim. (May 2008 data, which became available after discontinuation of oral fluid testing in the STD clinics, showed that the recent increase in false-positive results had subsided), the CDC reported. From March 2005 through May 2008, the NYC DOHMH administered 160,174 oral fluid rapid tests, of which 0.27% of the tests were confirmed false positive results. Thus, overall the oral fluid rapid test performed well and within the manufacturer's limits described in the package insert. It should also be noted that during all months described in this report the test operated within the Food and Drug Administration regulations, which call for a minimum threshold of 98.0% specificity, that is, the probability that the test will be negative among patients who do not have the infection.
The agency continues to support the use of rapid oral fluid HIV tests. However, in general, FDA-approved testing with blood or serum specimens is more accurate than testing with oral fluid. In settings where blood specimens are already obtained routinely, testing with blood or serum specimens is preferred. NYC's experience demonstrates that repeating the same rapid test on fingerstick whole blood after a reactive oral fluid test result can reduce the number of false-positive test results while minimizing the number of fingerstick tests that must be performed. Even when a follow-up rapid test is performed after a reactive oral fluid test, confirmatory testing is still required.
Reference
- Centers for Disease Control and Prevention. False-Positive Oral Fluid Rapid HIV Tests — New York City, 2005-2008. MMWR June 18, 2008 / 57 (Early Release);1-5 Available at: www.cdc.gov.
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