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FDA Approves Generic Truvada for HIV Treatment and PrEP - POZ
FDA Approves Generic Truvada for HIV Treatment and PrEP - POZ
Jun 9, 2017 ... In a move that has taken HIV advocates by surprise and stewed considerable confusion, the U.S. Food and Drug Administration (FDA) has approved a generic formulation of Gilead Sciences' blockbuster antiretroviral (ARV) Truvada ( tenofovir disoproxil fumarate/emtricitabine). This decision could have ...

A Teva spokesperson confirmed the generic Truvada approval but said no further related information was available at this time. The Gilead statement noted that the patent for the tenofovir disoproxil fumarate component of Truvada expires in July 2017 and that Gilead retains exclusive rights for the drug’s pediatric use until January 2018. Consequently, it remains unclear what sort of exclusivity Teva may have to produce generic Truvada.

According to the company’s statement, “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. Signs look promising that Gilead will indeed continue supporting PrEP use among individuals at risk for HIV, at least in the near term. According to Martin Shimer, RPh, deputy director of the Office of Generic Drug Policy at the FDA, the paragraph IV certification for Truvada indicates that Teva applied for an abbreviated new drug application (ANDA), challenging Gilead’s patent on the combination tablet and seeking the rights to produce a generic equivalent. Tim Horn, deputy executive director of HIV and HCV programs at Treatment Action Group, told POZ. However, such an ultimate result is not necessarily off the table.

FDA Approves First Generic Version of Truvada - MPR
Jun 9, 2017 ... The Food and Drug Administration (FDA) has approved Teva's Emtricitabine and Tenofovir Disoproxil Fumarate Tablets 200mg/300mg, the first generic version of Gilead's Truvada 200mg/300mg. Teva's product was determined to be bioequivalent and therapeutically equivalent to the reference drug. porta truvada generic How more Ontarians could gain access to a '99.9%' effective HIV ...Aug 3, 2017 ... A generic version of an effective HIV-prevention drug has come on the market in the past few days, but experts say the medication is still far too expensive ... On July 26, Health Canada also approved generic versions of Truvada for use in Canada from Mylan Pharmaceuticals, Pharmascience Inc. and Teva ... Emtricitabine/tenofovir - WikipediaEmtricitabine/tenofovir, sold under the brand name Truvada among others, is a medication used to treat and prevent HIV/AIDS. It is a fixed-dose combination of two antiretroviral medications: tenofovir disoproxil and emtricitabine. For treatment it is used either alone or together with other antiretroviral medication.
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