Efavirenz/lamivudine/tenofovir disoproxil fumarate

Drug Profile

Efavirenz/lamivudine/tenofovir disoproxil fumarate

Alternative Names: 3TC/EFV/TDF; Efavirenz 400mg/lamivudine 300mg/tenofovir disoproxil fumarate 300mg; Efavirenz 600mg/lamivudine 300mg/tenofovir disoproxil fumarate 300mg; Efavirenz/tenofovir disoproxil fumarate/lamivudine; EFV/3TC/TDF; EFV/TDF/3TC; Lamivudine/efavirenz/tenofovir disoproxil fumarate; Lamivudine/tenofovir disoproxil fumarate/efavirenz; TDF/3TC/EFV; Telura; Tenofovir disoproxil fumarate/efavirenz/lamivudine; TLE400

Latest Information Update: 14 Oct 2015

Price : $50

At a glance

  • Originator Matrix Laboratories
  • Developer Mylan Laboratories Limited; The HIV Netherlands Australia Thailand Research Collaboration
  • Class Antiretrovirals; Benzoxazines; Deoxyribonucleosides; Dideoxynucleosides; Phosphonic acids; Purines; Pyrimidine nucleosides
  • Mechanism of Action Non-nucleoside reverse transcriptase inhibitors; Nucleoside reverse transcriptase inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

    No
  • New Molecular Entity No

Highest Development Phases

  • Marketed HIV-1 infections

Most Recent Events

  • 29 Jun 2015 Efavirenz/lamivudine/tenofovir disoproxil fumarate still has tentative approval for HIV-1 infections in USA
  • 25 Mar 2015 The HIV Netherlands Australia Thailand Research Collaboration and Mylan complete enrolment in a phase II trial for HIV-1 infections in Thailand (NCT01160120)
  • 08 Nov 2012 The US FDA issues tentative approval to efavirenz/lamivudine/tenofovir disoproxil fumarate 600mg/300mg/300mg tablets for use as monotherapy or combination with antiretrovirals for HIV-1 infections in adults and paediatric patients ≥40kg
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