Viral Hepatitis

• FDA approval · 2013-12-04
  FDA Approved: KIT FOR THE PREPARTION OF TECHNETIUM TC99M SULFUR COLLOID — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for a kit used to prepare Technetium-99m sulfur colloid for nuclear medicine imaging.

• FDA approval · 2013-11-08
  FDA Approved: EMTRIVA — Supplemental Application (Gilead Sciences, Inc.)

  FDA approved a supplemental application for EMTRIVA (emtricitabine) submitted by Gilead Sciences.

• FDA approval · 2013-05-16
  FDA Approved: PEGASYS — Supplemental Application (pharmaand GmbH)

  FDA approved a supplemental application for PEGASYS (peginterferon alfa-2a) submitted by pharmaand GmbH.

• FDA approval · 2013-04-02
  FDA Approved: EMTRIVA — Supplemental Application (Gilead Sciences, Inc.)

  FDA approved a supplemental application for EMTRIVA (emtricitabine) submitted by Gilead Sciences.

• FDA approval · 2012-12-18
  FDA Approved: EPIVIR — Supplemental Application (ViiV Healthcare Company)

  The FDA approved a supplemental application for EPIVIR (lamivudine) submitted by ViiV Healthcare Company. The approval updates the labeling …

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• FDA approval · 2012-08-07
  FDA Approved: VIREAD — Supplemental Application (Gilead Sciences, Inc.)

  The FDA approved a supplemental application for Viread (tenofovir disoproxil fumarate) submitted by Gilead Sciences, Inc., resulting in chan…

• FDA approval · 2012-08-07
  FDA Approved: VIREAD — Supplemental Application (Gilead Sciences, Inc.)

  The FDA approved a supplemental application for VIREAD (tenofovir disoproxil fumarate) submitted by Gilead Sciences, Inc. to update or expan…

• FDA approval · 2012-07-23
  FDA Approved: EMTRIVA — Supplemental Application (Gilead Sciences, Inc.)

  FDA approved a supplemental application for Emtriva (emtricitabine) by Gilead Sciences.

• FDA approval · 2011-11-18
  FDA Approved: EPIVIR — Supplemental Application (ViiV Healthcare Company)

  The FDA approved a supplemental application for EPIVIR (lamivudine) submitted by ViiV Healthcare Company, potentially updating labeling or e…

• FDA approval · 2011-11-18
  FDA Approved: EPIVIR — Supplemental Application (ViiV Healthcare Company)

  FDA approved a supplemental application for Epivir (lamivudine) submitted by ViiV Healthcare Company.

• FDA approval · 2011-11-16
  FDA Approved: RIBAVIRIN — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for ribavirin from Aurobindo Pharma Limited, authorizing the generic ribavirin product.

• FDA approval · 2011-09-29
  FDA Approved: PEGASYS — Supplemental Application (pharmaand GmbH)

  The FDA approved a supplemental application for PEGASYS (peginterferon alfa-2a) submitted by pharmaand GmbH. The approval reflects an additi…

• FDA approval · 2011-08-22
  FDA Approved: PEGASYS — Supplemental Application (pharmaand GmbH)

  FDA approved a supplemental application for PEGASYS (peginterferon alfa-2a) submitted by pharmaand GmbH.

• FDA approval · 2011-05-27
  FDA Approved: PEGASYS — Supplemental Application (pharmaand GmbH)

  FDA approved a supplemental application for PEGASYS (peginterferon alfa-2a) submitted by pharmaand GmbH.

• FDA approval · 2011-05-09
  FDA Approved: PEGASYS — Supplemental Application (pharmaand GmbH)

  FDA approved a supplemental application for PEGASYS (peginterferon alfa-2a) filed by pharmaand GmbH.

• FDA approval · 2011-03-16
  FDA Approved: RIBAVIRIN — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for ribavirin by Aurobindo Pharma Limited (ANDA 079111).

• FDA approval · 2011-02-23
  FDA Approved: PEGASYS — Supplemental Application (pharmaand GmbH)

  FDA approved a supplemental application for PEGASYS (peginterferon alfa-2a) filed by pharmaand GmbH.

• FDA approval · 2010-03-24
  FDA Approved: VIREAD — Supplemental Application (Gilead Sciences, Inc.)

  FDA approved a supplemental application for VIREAD (tenofovir disoproxil fumarate) from Gilead Sciences, Inc.

• FDA approval · 2009-11-10
  FDA Approved: VIREAD — Supplemental Application (Gilead Sciences, Inc.)

  The FDA approved a supplemental application for VIREAD (tenofovir disoproxil fumarate) submitted by Gilead Sciences, Inc. This action update…

• FDA approval · 2009-09-17
  FDA Approved: RIBAVIRIN — Original Application (Aurobindo Pharma Limited)

  FDA approved Ribavirin as an Original Application (ANDA) from Aurobindo Pharma Limited, authorizing a generic ribavirin product.

• FDA approval · 2009-08-07
  FDA Approved: PEGASYS — Supplemental Application (pharmaand GmbH)

  FDA approved a supplemental application for PEGASYS (peginterferon alfa-2a) from pharmaand GmbH.

• FDA approval · 2009-04-20
  FDA Approved: PEGASYS — Supplemental Application (pharmaand GmbH)

  FDA approved a supplemental application for PEGASYS (pegylated interferon alfa-2a) submitted by pharmaand GmbH.

• FDA approval · 2008-11-04
  FDA Approved: VIREAD — Supplemental Application (Gilead Sciences, Inc.)

  The FDA approved a supplemental application for VIREAD (tenofovir disoproxil fumarate) submitted by Gilead Sciences, indicating changes to i…

• FDA approval · 2008-08-11
  FDA Approved: VIREAD — Supplemental Application (Gilead Sciences, Inc.)

  The FDA approved a supplemental application for VIREAD (tenofovir disoproxil fumarate) by Gilead Sciences, Inc., updating the product's labe…

• FDA approval · 2008-06-13
  FDA Approved: PEGASYS — Supplemental Application (pharmaand GmbH)

  FDA approves a supplemental application for PEGASYS (peginterferon alfa-2a) submitted by pharmaand GmbH.