Are your medications FDA-approved?

Mylan and Cipla are the companies that produce the generic emtricitabine/tenofovir (Ricovir-EM and Tenvir-EM, respectively). Mylan is the second largest manufacturer of generic medication in the world. Cipla is also a large generic medicine manufacturer, with over one million people living with HIV currently taking their anti-retrovirals worldwide.

Both of these companies’ formulations of emtricitabine/tenofovir have received tentative approval by the United States Food & Drug Administration (US FDA). See 087 on the list for Mylan and 168 for Cipla. ‘Tentative’ FDA approval means:

If the product still has marketing protection in the U.S., FDA issues a “tentative approval” rather than a “full” approval. The “tentative” approval signifies that the product meets all safety, efficacy, and manufacturing quality standards for marketing in the U.S., and, but for the legal market protection, it would be on the U.S. market.

Mylan’s product was approved by Health Canada on 31-July-2017. It is available in some Canadian pharmacies for approximately $250/month. Cipla’s product has not been reviewed by Health Canada.

In summary, this status of FDA approval means that this version of generic emtricitabine/tenofovir is equivalent to the brand name and meets all quality standards  that would allow it to be on the shelves of US pharmacies next to Truvada®, if this were not legally prohibited due to Gilead’s patent.

 

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