FDA Brief: Week of Feb 29, 2016


FDA approved



Center for Disease Control (CDC)

Intended Use:  qualitative detection of Zika virus IgM antibodies in human sera or cerebrospinal fluid that is submitted alongside a patient-matched serum specimen, collected from individuals meeting CDC Zika virus clinical criteria and/or CDC Zika virus epidemiological criteria.

  • For use in CDC qualified laboratories as a part of a multi-test algorithm
  • For presumptive identification of IgM antibodies to Zika virus
  • Confirmation requires additional CDC testing using the CDC-issued algorithm
  • Results cannot be used as the sole basis of patient management decisions and must be combined with clinical observations, patient history, epidemiological information, and other laboratory evidences.

Reg pathway: Emergency Use Authorization

Mechanism of Action: IgM antibody capture enzyme-linked immunosorbent assay for the in vitro qualitative detection of Zika virus-specific IgM antibodies in human sera and other authorized specimen types

Criteria for Issuance of Authorization

  • The Zika virus can cause Zika virus infection, a serious or life-threatening disease orcondition to humans infected with the virus
  • Totality of scientific evidence available to FDA, Zika MAC-ELISA may be effective in diagnosing Zika virus infection when positive or equivocal results are further tested by CDC or by authorized laboratories
  • Known and potential benefits of the Zika MAC-ELISA for diagnosing Zika virus infection outweigh the known and potential risks of such product when tested CDC standards
  • There is no adequate, approved, and available alternative to the emergency use of the Zika MAC-ELISA for diagnosing Zika virus infection.

Conditions of Authorization for CDC

  • Distribution only to authorized laboratories
  • HCP, Pregnant women and patient fact sheets on CDC website
  • Inform and set standards for authorized laboratories
  • Tack adverse events and report to FDA





Secretary of Health and Human Services (HHS) issued notice authorizing the emergency use of in vitro diagnostic tests for detection  and/or diagnosis of Zika virus infection




ODEFSEY (emtricitabine, rilpivirine, and tenofovir alafenamide),  fixed-dose combination tablet

Gilead Sciences, Foster City, CA

Indication:  Complete regimen for treatment of HIV-1 infection in patients 12 years of age and older as initial therapy in those with no antiretroviral treatment history with HIV-1 RNA less than or equal to 100,000 copies per mL; or to replace a stable antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies per mL) for at least six months with no history of treatment failure and no known substitutions associated with resistance to the individual components of ODEFSEY

Reg Strategy:  505(b),  Gilead Access Program

Mechanism of Action:

  • Emtricitabine: Inhibits activity of HIV-1 reverse transcriptase
  • Rilpivirine: Reverse transcriptase inhibitor and inhibits HIV-1 replication
  •  Tenofovir Alafenamide (TAF): Inhibits HIV-1 replication through incorporation into viral DNA

Clinical Data: 

Bioequivalence study demonstrating

  • Similar exposure of emtricitabine and TAF as Genvoya®
  • Similar exposure of rilpivirine as Edurant® (rilpivirine 25 mg).

Safety, efficacy and tolerability supported by  clinical studies in a wide range of patients with HIV.

Approved label


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