Viral Hepatitis

• FDA label_change · 2015-12-31
  FDA Approved: LAMIVUDINE — Supplemental Application (Apotex Corp.)

  FDA approved a supplemental application for lamivudine by Apotex Corp., indicating a labeling-related change under the ANDA.

• FDA label_change · 2015-05-29
  FDA Approved: VIREAD — Supplemental Application (Gilead Sciences, Inc.)

  FDA approved a supplemental application for VIREAD (tenofovir disoproxil fumarate), authorizing changes to the product's labeling. The chang…

• FDA label_change · 2010-05-24
  FDA Approved: PEGASYS — Supplemental Application (pharmaand GmbH)

  FDA approved a supplemental application for PEGASYS (peginterferon alfa-2a) submitted by pharmaand GmbH, associated with a labeling update o…

• FDA label_change · 2008-04-04
  FDA Approved: EMTRIVA — Supplemental Application (Gilead Sciences, Inc.)

  The FDA approved a supplemental application for Emtriva (emtricitabine) to update its labeling, reflecting changes approved for the product.