Petition · Dr. Janet Woodcock: The FDA Must Disclose All Potential Side Effects of Harvoni, Hepatitis C Medication · Change.org

It is estimated that 150 million people world-wide may have the Hepatitis C Virus. On October 10, 2014, the FDA approved the fixed-dose combination capsule of ledipasvir plus sofosbuvir (Harvoni; Gilead Sciences) for the treatment of patients with chronic HCV genotype 1 infection. Ledipasvir plus sofosbuvir is the first combination tablet approved for the treatment of patients with chronic HCV genotype 1 infection, as well as, the first approved regimen that does not require the use of interferon or ribavirin.  The FDA approved the drug under breakthrough therapy designation, which is intended to expedite the development and review of drugs for serious conditions.

Source: Petition · Dr. Janet Woodcock: The FDA Must Disclose All Potential Side Effects of Harvoni, Hepatitis C Medication · Change.org

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