FDA Approves Generic Truvada
 
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FDA Approves Generic Truvada
 
 
  Gilead Statement:
 
FDA has granted Teva Phamaceuticals approval to produce a generic version of Truvada. It's important to note that there are number of factors involved in commercialization that are not tied directly to FDA approval.
 
A generic version of Truvada will not be immediately available. The patent for tenofovir disoproxil fumarate (TDF), a component of Truvada, expires July 2017 and has pediatric exclusivity until January 2018. The patent for emtricitabine, a component of Truvada, expires in 2021.
 
Gilead believes Truvada for PrEP is an important HIV prevention tool and we remain committed to helping ensure access to our medications for people both at risk of or living with HIV.
 
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FDA Approves Generic Truvada
 
On June 8, 2017, the Food and Drug Administration approved the first generic version of emtricitabine and tenofovir disoproxil fumarate tablets, 200 mg/300 mg, determined to be bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Truvada Tablets, 200 mg/300 mg.
 
The drug is indicated for the treatment of HIV-1, in combination with other antiretroviral agents in adults and pediatric patients weighing at least 17 kg, and for pre-exposure prophylaxis (PrEP) in combination with safer sex practices to prevent sexually-acquired HIV infection in adults at high risk.
 
Emtricitabine and tenofovir disoproxil fumarate must be dispensed with a Medication Guide for patients, which provides important information about the medication's use and risks. Emtricitabine and tenofovir disoproxil fumarate must be used as directed by the physician and should be taken by mouth only. If you have kidney problems, your healthcare provider may tell you to take emtricitabine and tenofovir disoproxil fumarate less often. Do not change your dose or stop taking emtricitabine and tenofovir disoproxil fumarate without first talking with your healthcare provider. Stay under a healthcare provider's care when taking emtricitabine and tenofovir disoproxil fumarate.
 
Emtricitabine and tenofovir disoproxil fumarate used for PrEP must only be prescribed to individuals confirmed to be HIV-negative immediately prior to initial use and periodically during use. Drug-resistant HIV-1 variants have been identified with the use of emtricitabine and tenofovir disoproxil fumarate for PrEP following undetected acute HIV-1 infection. Do not initiate emtricitabine and tenofovir disoproxil fumarate for a PrEP indication if signs or symptoms of acute HIV infection are present unless negative infection status is confirmed.
 
Women infected with HIV-1 should be instructed not to breastfeed while taking
emtricitabine and tenofovir disoproxil fumarate.
 
More information on emtricitabine and tenofovir disoproxil fumarate may be found within the drug label at Drugs@FDA.
 
The generic formulation is a product of Teva Pharmaceuticals USA.
 
Richard Klein
- Office of Health and Constituent Affairs
Food and Drug Administration
 
Kimberly Struble
- Division of Antiviral Products
Food and Drug Administration
 
Steve Morin
- Office of Health and Constituent Affairs
Food and Drug Administration

 
 
 
 
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