October 2, 2020

Teva Pharmaceuticals has announced the launch of generics for Gilead’s Truvada (emtricitabine/tenofovir disoproxil fumarate) and Atripla (efavirenz/emtricitabine/tenofovir disoproxil fumarate).

Truvada and its generic are approved for use in combination with other antiretroviral agents to treat HIV-1 infection in adults and pediatric patients who weigh at least 17kg (37 pounds), as well as for use alone to provide pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in at-risk adults and adolescents who weight at least 35kg (77 pounds).

Recommended dosing for Truvada and its generic is based on the indication. A black box warning cautions there is a risk of severe, acute exacerbations of hepatitis B virus (HBV) in coinfected individuals following discontinuation of products that contain emtricitabine and/or tenofovir disoproxil fumarate. An additional black box warning cautions that, when used for HIV-1 PrEP, Truvada and its generic must only be prescribed to individuals confirmed to be HIV-negative immediately prior to initiating treatment and at least once every three months while using the medication.

Also approved to treat HIV-1 infection, Atripla and its generic are indicated for use as a complete regimen or in combination with other antiretroviral agents. Patients should weigh at least 40kg (88 pounds). Recommended dosing is based on factors that include the patient’s age, weight, renal health, and whether the patient is also taking rifampin, an antibiotic. Atripla and its generic also carry a black box warning for the risk of severe, acute exacerbations of HBV in patients coinfected with HBV and HIV-1 who have discontinued products containing emtricitabine and/or tenofovir disoproxil fumarate.

Teva has priced its generics at an approximately 21% discount compared to the brand name versions.

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