HIV Infection

• FDA label_change · 2024-11-13
  FDA Approved: SUNLENCA — Supplemental Application (Gilead Sciences, Inc.)

  FDA approved a supplemental application for Sunlenca (lenacapavir sodium) from Gilead Sciences, Inc., updating the drug’s labeling.

• FDA label_change · 2024-04-18
  FDA Approved: TRIUMEQ PD — Supplemental Application (ViiV Healthcare Company)

  FDA approved a supplemental application for TRIUMEQ PD (abacavir sulfate, dolutegravir sodium, lamivudine) from ViiV Healthcare. This result…

• FDA label_change · 2023-12-12
  FDA Approved: TROGARZO — Supplemental Application (Theratechnologies Inc.)

  FDA approved a supplemental application for TROGARZO (ibalizumab) filed by Theratechnologies, resulting in changes to the product labeling.

• FDA label_change · 2022-10-07
  FDA Approved: TIVICAY PD — Supplemental Application (ViiV Healthcare Company)

  The FDA approved a supplemental application for Tivicay PD (dolutegravir sodium) submitted by ViiV Healthcare Company.

• FDA label_change · 2022-04-14
  FDA Approved: SYMTUZA — Supplemental Application (Janssen Products LP)

  FDA approved Janssen's supplemental application for SYMTUZA, updating its labeling for the fixed-dose combination of darunavir, cobicistat, …

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA label_change · 2021-07-09
  FDA Approved: JULUCA — Supplemental Application (ViiV Healthcare Company)

  FDA approved a supplemental application for JULUCA (dolutegravir and rilpivirine) submitted by ViiV Healthcare Company to update the labelin…

• FDA label_change · 2021-04-22
  FDA Approved: TROGARZO — Supplemental Application (Theratechnologies Inc.)

  The FDA approved a supplemental application for TROGARZO (ibalizumab) from Theratechnologies Inc., resulting in a revised product label.

• FDA label_change · 2020-12-22
  FDA Approved: PREZCOBIX — Supplemental Application (Janssen Products, LP)

  FDA approved a supplemental application for PrezcoBix (darunavir ethanolate and cobicistat) from Janssen Products, LP. This action updates t…

• FDA label_change · 2020-10-30
  FDA Approved: SELZENTRY — Supplemental Application (ViiV Healthcare Company)

  The FDA approved a supplemental application for SELZENTRY (maraviroc) submitted by ViiV Healthcare. The approval results in changes to the l…

• FDA label_change · 2020-07-31
  FDA Approved: PREZCOBIX — Supplemental Application (Janssen Products, LP)

  FDA approved a supplemental application for PREZCOBIX (darunavir ethanolate and cobicistat) submitted by Janssen, resulting in a label updat…

• FDA label_change · 2019-12-03
  FDA Approved: DESCOVY — Supplemental Application (Gilead Sciences, Inc.)

  FDA approved a supplemental application for DESCOVY (emtricitabine and tenofovir alafenamide) from Gilead Sciences, Inc., resulting in a lab…

• FDA label_change · 2019-10-24
  FDA Approved: JULUCA — Supplemental Application (ViiV Healthcare Company)

  FDA approved a supplemental application for JULUCA (dolutegravir sodium and rilpivirine hydrochloride) submitted by ViiV Healthcare Company,…

• FDA label_change · 2019-01-31
  FDA Approved: PREZISTA — Supplemental Application (Janssen Products LP)

  The FDA approved a supplemental application for Prezista (darunavir) filed by Janssen Products LP. The approval pertains to changes to the p…

• FDA label_change · 2018-07-18
  FDA Approved: SELZENTRY — Supplemental Application (ViiV Healthcare Company)

  FDA approves a supplemental labeling change for SELZENTRY (maraviroc) submitted by ViiV Healthcare Company, updating the product labeling fo…

• FDA label_change · 2017-01-27
  FDA Approved: STRIBILD — Supplemental Application (Gilead Sciences, Inc.)

  FDA approved a supplemental application for Stribild, updating the product labeling for this fixed-dose HIV-1 regimen.

• FDA label_change · 2016-09-22
  FDA Approved: PREZCOBIX — Supplemental Application (Janssen Products, LP)

  FDA approved a supplemental application for PREZCOBIX (darunavir ethanolate and cobicistat), updating the labeling for this HIV-1 infection …

• FDA label_change · 2016-03-10
  FDA Approved: TRUVADA — Supplemental Application (Gilead Sciences, Inc)

  The FDA approved a supplemental application for Truvada (emtricitabine/tenofovir disoproxil fumarate) from Gilead Sciences to update the pro…

• FDA label_change · 2016-03-09
  FDA Approved: COMPLERA — Supplemental Application (Gilead Sciences, Inc.)

  FDA approved a supplemental application for COMPLERA (emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil fumarate) submitted…

• 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 · 2015-09-30
  FDA Approved: ZIAGEN — Supplemental Application (ViiV Healthcare Company)

  The FDA approved a supplemental application for Ziagen (abacavir sulfate) submitted by ViiV Healthcare Company, resulting in updated labelin…

• FDA label_change · 2015-08-26
  FDA Approved: EDURANT — Supplemental Application (Janssen Products, LP)

  The FDA approved Janssen's supplemental application for EDURANT (rilpivirine hydrochloride), updating the labeling for the product as reques…

• 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 · 2014-03-25
  FDA Approved: EMTRIVA — Supplemental Application (Gilead Sciences, Inc.)

  The FDA approved a supplemental application for Emtriva (emtricitabine) submitted by Gilead Sciences, Inc.

• FDA label_change · 2014-02-26
  FDA Approved: REYATAZ — Supplemental Application (E.R. Squibb & Sons, L.L.C.)

  FDA approved a supplemental application for Reyataz (atazanavir) to update the labeling following submission by E.R. Squibb & Sons, L.L.C.

• FDA label_change · 2013-12-13
  FDA Approved: COMPLERA — Supplemental Application (Gilead Sciences, Inc.)

  The FDA approved a supplemental application for COMPLERA (emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil fumarate) from …