Hepatitis C

• FDA approval · 2017-12-11
  FDA Approved: MAVYRET — Supplemental Application (AbbVie Inc.)

  The FDA approved a supplemental application for MAVYRET (glecaprevir and pibrentasvir) submitted by AbbVie, updating its regulatory status f…

• FDA approval · 2017-11-09
  FDA Approved: SOVALDI — Supplemental Application (Gilead Sciences, Inc.)

  FDA approved a supplemental application for Sovaldi (sofosbuvir) submitted by Gilead Sciences, Inc., expanding its approved use.

• FDA approval · 2017-11-09
  FDA Approved: LEDIPASVIR AND SOFOSBUVIR — Supplemental Application (Asegua Therapeutics LLC)

  The FDA approved a supplemental application for ledipasvir/sofosbuvir from Asegua Therapeutics LLC.

• FDA approval · 2017-11-09
  FDA Approved: EPCLUSA — Supplemental Application (Gilead Sciences, Inc.)

  The FDA approved a supplemental application for Epclusa (velpatasvir/sofosbuvir) from Gilead Sciences, expanding its approved uses for hepat…

• FDA approval · 2017-11-09
  FDA Approved: VOSEVI — Supplemental Application (Gilead Sciences, Inc.)

  FDA approved a supplemental application for VOSEVI (sofosbuvir, velpatasvir, voxilaprevir) from Gilead Sciences, Inc.

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• FDA approval · 2017-08-31
  FDA Approved: EPCLUSA — Supplemental Application (Gilead Sciences, Inc.)

  FDA approved a supplemental application for Epclusa (velpatasvir/sofosbuvir) by Gilead Sciences.

• FDA approval · 2017-08-03
  FDA Approved: MAVYRET — Original Application (AbbVie Inc.)

  FDA approved MAVYRET (glecaprevir and pibrentasvir) from AbbVie in an Original Application for the treatment of hepatitis C virus infection.

• FDA approval · 2017-08-01
  FDA Approved: EPCLUSA — Supplemental Application (Gilead Sciences, Inc.)

  FDA approved a supplemental application for Epclusa (velpatasvir/sofosbuvir) submitted by Gilead Sciences, Inc., resulting in an update to t…

• FDA approval · 2017-07-18
  FDA Approved: VOSEVI — Original Application (Gilead Sciences, Inc.)

  VOSEVI (sofosbuvir/velpatasvir/voxilaprevir) is approved as an oral, fixed-dose combination for treatment of chronic hepatitis C virus infec…

• EMA approval · 2017-06-23
  Two new medicines recommended for the treatment of chronic hepatitis C

  EMA recommended two new medicines for the treatment of chronic hepatitis C, indicating potential upcoming approvals for improved regimens.

• FDA approval · 2017-04-07
  FDA Approved: LEDIPASVIR AND SOFOSBUVIR — Supplemental Application (Asegua Therapeutics LLC)

  The FDA approved a supplemental application for ledipasvir and sofosbuvir (Asegua Therapeutics LLC).

• FDA approval · 2017-02-14
  FDA Approved: EPCLUSA — Supplemental Application (Gilead Sciences, Inc.)

  The FDA approved a supplemental application for Epclusa (sofosbuvir/velpatasvir) submitted by Gilead Sciences, Inc., indicating an extension…

• FDA approval · 2017-02-14
  FDA Approved: LEDIPASVIR AND SOFOSBUVIR — Supplemental Application (Asegua Therapeutics LLC)

  FDA approved a supplemental application for ledipasvir and sofosbuvir from Asegua Therapeutics LLC.

• FDA approval · 2017-02-14
  FDA Approved: SOVALDI — Supplemental Application (Gilead Sciences, Inc.)

  The FDA approved a supplemental application for Sovaldi (sofosbuvir) submitted by Gilead Sciences, Inc. The decision pertains to hepatitis C…

• FDA approval · 2017-01-10
  FDA Approved: ZEPATIER — Supplemental Application (Merck Sharp & Dohme LLC)

  FDA approved a supplemental application for ZEPATIER (elbasvir and grazoprevir) from Merck Sharp & Dohme LLC.

• FDA approval · 2016-06-28
  FDA Approved: EPCLUSA — Original Application (Gilead Sciences, Inc.)

  FDA approved EPCLUSA (ledipasvir/sofosbuvir) in its original application for the treatment of chronic hepatitis C infection.

• FDA approval · 2016-06-22
  FDA Approved: LEDIPASVIR AND SOFOSBUVIR — Supplemental Application (Asegua Therapeutics LLC)

  FDA approved a supplemental application for Ledipasvir and Sofosbuvir from Asegua Therapeutics LLC. The action updates the product labeling …

• FDA approval · 2016-06-08
  FDA Approved: LEDIPASVIR AND SOFOSBUVIR — Supplemental Application (Asegua Therapeutics LLC)

  FDA approved a supplemental application for Ledipasvir and Sofosbuvir from Asegua Therapeutics LLC.

• EMA approval · 2016-05-27
  Two new combination therapies against chronic hepatitis C

  The EMA announces two new combination therapies for chronic hepatitis C, expanding treatment options.

• FDA approval · 2016-02-17
  FDA Approved: LEDIPASVIR AND SOFOSBUVIR — Supplemental Application (Asegua Therapeutics LLC)

  FDA approved a supplemental application for Ledipasvir and Sofosbuvir (Asegua Therapeutics LLC). This action concerns the hepatitis C therap…

• FDA approval · 2016-02-12
  FDA Approved: LEDIPASVIR AND SOFOSBUVIR — Supplemental Application (Asegua Therapeutics LLC)

  FDA approved a supplemental NDA for Ledipasvir and Sofosbuvir from Asegua Therapeutics LLC, approving a generic combination product for hepa…

• FDA approval · 2016-01-28
  FDA Approved: ZEPATIER — Original Application (Merck Sharp & Dohme LLC)

  FDA approved ZEPATIER, a fixed-dose combination of elbasvir and grazoprevir, for the treatment of chronic hepatitis C virus infection in adu…

• FDA approval · 2015-11-12
  FDA Approved: LEDIPASVIR AND SOFOSBUVIR — Supplemental Application (Asegua Therapeutics LLC)

  The FDA approved a supplemental application for ledipasvir/sofosbuvir by Asegua Therapeutics LLC. This action pertains to the hepatitis C tr…

• FDA approval · 2015-08-19
  FDA Approved: SOVALDI — Supplemental Application (Gilead Sciences, Inc.)

  FDA approved a supplemental application for Sovaldi (sofosbuvir) submitted by Gilead Sciences.

• FDA approval · 2015-03-20
  FDA Approved: LEDIPASVIR AND SOFOSBUVIR — Supplemental Application (Asegua Therapeutics LLC)

  The FDA approved a supplemental application for Ledipasvir and Sofosbuvir (Harvoni) submitted by Asegua Therapeutics LLC.