Viral Hepatitis

• FDA approval · 2025-08-20
  FDA Approved: LAMIVUDINE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application to authorize lamivudine oral (generic) from Chartwell RX, LLC.

• FDA approval · 2025-05-08
  FDA Approved: LAMIVUDINE — Supplemental Application (Camber Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for lamivudine submitted by Camber Pharmaceuticals, expanding the approved product to lamivudine…

• FDA approval · 2024-12-04
  FDA Approved: EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE — Supplemental Application (Zydus Pharmaceuticals USA Inc.)

  FDA approves a supplemental application for Emtricitabine and Tenofovir Disoproxil Fumarate by Zydus Pharmaceuticals USA Inc., confirming re…

• FDA approval · 2024-11-21
  FDA Approved: EMTRICITABINE — Supplemental Application (Cipla USA Inc.)

  FDA approved a supplemental application for Emtricitabine submitted by Cipla USA Inc., updating the approved labeling for the drug.

• FDA approval · 2023-12-11
  FDA Approved: PEGASYS — Supplemental Application (pharmaand GmbH)

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

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• FDA approval · 2023-10-11
  FDA Approved: TENOFOVIR DISOPROXIL FUMARATE — Supplemental Application (Quinn Pharmaceuticals)

  The FDA approved a supplemental application for Tenofovir disoproxil fumarate from Quinn Pharmaceuticals, granting approval of its generic p…

• FDA approval · 2023-05-05
  FDA Approved: LAMIVUDINE — Supplemental Application (Apotex Corp.)

  FDA approved a supplemental application for lamivudine by Apotex Corp., enabling the generic lamivudine product to be marketed.

• FDA approval · 2022-08-31
  FDA Approved: TENOFOVIR DISOPROXIL FUMARATE — Supplemental Application (Macleods Pharmaceuticals Limited)

  FDA approved a supplemental application for tenofovir disoproxil fumarate filed by Macleods Pharmaceuticals Limited under the ANDA process.

• FDA approval · 2022-03-31
  FDA Approved: PROMACTA — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for PROMACTA (eltrombopag olamine) from Novartis Pharmaceuticals Corporation.

• FDA approval · 2021-03-24
  FDA Approved: PEGASYS — Supplemental Application (pharmaand GmbH)

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

• FDA approval · 2021-03-08
  FDA Approved: EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE — Supplemental Application (Zydus Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for a generic emtricitabine and tenofovir disoproxil fumarate product from Zydus Pharmaceuticals USA…

• FDA approval · 2021-01-26
  FDA Approved: LAMIVUDINE — Supplemental Application (Apotex Corp.)

  FDA approves a supplemental abbreviated new drug application for Lamivudine from Apotex Corp., authorizing the continued manufacture and dis…

• FDA approval · 2020-10-15
  FDA Approved: PEGASYS — Supplemental Application (pharmaand GmbH)

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

• FDA approval · 2020-06-11
  FDA Approved: LAMIVUDINE — Supplemental Application (Macleods Pharmaceuticals Limited)

  FDA approved a supplemental application for Lamivudine from Macleods Pharmaceuticals Limited.

• FDA approval · 2020-01-23
  FDA Approved: TENOFOVIR DISOPROXIL FUMARATE — Supplemental Application (Camber Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Camber Pharmaceuticals’ generic tenofovir disoproxil fumarate.

• FDA approval · 2019-11-20
  FDA Approved: TENOFOVIR DISOPROXIL FUMARATE — Supplemental Application (Chartwell RX, LLC.)

  FDA approved a supplemental application for Tenofovir disoproxil fumarate tablets from Chartwell RX, LLC. This approval authorizes the marke…

• FDA approval · 2019-11-19
  FDA Approved: TENOFOVIR DISOPROXIL FUMARATE — Supplemental Application (Strides Pharma Science Limited)

  FDA approved a supplemental application for tenofovir disoproxil fumarate from Strides Pharma Science Limited, updating/expanding the approv…

• FDA approval · 2019-11-19
  FDA Approved: TENOFOVIR DISOPROXIL FUMARATE — Supplemental Application (Cipla USA Inc.)

  The FDA approved Cipla USA Inc.'s supplemental application for tenofovir disoproxil fumarate.

• FDA approval · 2019-10-07
  FDA Approved: LAMIVUDINE — Supplemental Application (Ingenus Pharmaceuticals, LLC)

  FDA approved a supplemental application for lamivudine from Ingenus Pharmaceuticals, LLC, confirming authorization for a lamivudine product …

• FDA approval · 2019-10-03
  FDA Approved: LAMIVUDINE — Supplemental Application (Apotex Corp.)

  FDA approved a supplemental application for Apotex Corp.'s lamivudine, expanding access to a generic lamivudine product.

• FDA approval · 2019-09-26
  FDA Approved: LAMIVUDINE — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for lamivudine from Aurobindo Pharma Limited. This action relates to the approval of a supplemen…

• FDA approval · 2019-09-26
  FDA Approved: LAMIVUDINE — Supplemental Application (Strides Pharma Science Limited)

  FDA approved a supplemental application for Lamivudine from Strides Pharma Science Limited (ANDA 090457). This action confirms approval of a…

• FDA approval · 2019-08-29
  FDA Approved: LAMIVUDINE — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approval of a supplemental application for lamivudine by Rising Pharma Holdings, Inc.

• FDA approval · 2019-05-10
  FDA Approved: EPIVIR — Supplemental Application (ViiV Healthcare Company)

  FDA approved a supplemental application for EPIVIR (lamivudine) filed by ViiV Healthcare Company, resulting in label/indication changes thro…

• FDA approval · 2018-12-11
  FDA Approved: VIREAD — Supplemental Application (Gilead Sciences, Inc.)

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