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More Information on the Drug Approval Process

Letter to FDA Opposing Approval of Bedaquiline

December 21, 2012

View as PDF.

View press release.

Public Citizen strongly opposes the accelerated approval of bedaquiline because patients taking the drug, in addition to standard TB treatment,  during a phase 2 clinical trial were five times likelier to die than those who took a placebo.

January 16, 2013: FDA response to our letter

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