HIV Infection

• FDA approval · 2021-03-23
  FDA Approved: TIVICAY PD — Supplemental Application (ViiV Healthcare Company)

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

• FDA approval · 2021-03-23
  FDA Approved: TIVICAY — Supplemental Application (ViiV Healthcare Company)

  The FDA approved a supplemental application for Tivicay (dolutegravir) from ViiV Healthcare Company.

• FDA approval · 2021-03-23
  FDA Approved: TRIUMEQ — Supplemental Application (ViiV Healthcare Company)

  FDA approved a supplemental application for TRIUMEQ (abacavir sulfate, dolutegravir sodium, lamivudine) from ViiV Healthcare Company.

• FDA approval · 2021-03-23
  FDA Approved: JULUCA — Supplemental Application (ViiV Healthcare Company)

  FDA approved a supplemental application for JULUCA (dolutegravir + rilpivirine) from ViiV Healthcare Company.

• FDA approval · 2021-03-23
  FDA Approved: DOVATO — Supplemental Application (ViiV Healthcare Company)

  The FDA approved a supplemental application for DOVATO (dolutegravir and lamivudine) from ViiV Healthcare Company.

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• FDA approval · 2021-03-22
  FDA Approved: DRONABINOL — Supplemental Application (Wellhouse Pharma, LLC)

  FDA approved a supplemental application for dronabinol from Wellhouse Pharma, LLC.

• 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 · 2021-03-04
  FDA Approved: GENVOYA — Supplemental Application (Gilead Sciences, Inc.)

  The FDA page documents a supplemental application submission for GENVOYA (elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide…

• FDA approval · 2021-03-04
  FDA Approved: ODEFSEY — Supplemental Application (Gilead Sciences, Inc.)

  The FDA approved a supplemental application for ODEFSEY (emtricitabine, rilpivirine hydrochloride, and tenofovir alafenamide) from Gilead Sc…

• FDA approval · 2021-03-04
  FDA Approved: DESCOVY — Supplemental Application (Gilead Sciences, Inc.)

  The FDA approved a supplemental application for DESCOVY (emtricitabine and tenofovir alafenamide) from Gilead, updating the product labeling…

• FDA approval · 2021-03-04
  FDA Approved: BIKTARVY — Supplemental Application (Gilead Sciences, Inc.)

  FDA approved a supplemental application for BIKTARVY, submitted by Gilead Sciences, Inc.

• FDA approval · 2021-03-01
  FDA Approved: DOVATO — Supplemental Application (ViiV Healthcare Company)

  FDA approved a supplemental application for DOVATO, a fixed-dose combination of dolutegravir and lamivudine, developed by ViiV Healthcare.

• FDA approval · 2021-03-01
  FDA Approved: TRIUMEQ — Supplemental Application (ViiV Healthcare Company)

  The FDA approved a supplemental NDA for TRIUMEQ (abacavir sulfate, dolutegravir, lamivudine) from ViiV Healthcare Company.

• FDA approval · 2021-02-24
  FDA Approved: BIKTARVY — Supplemental Application (Gilead Sciences, Inc.)

  The FDA approved a supplemental application for BIKTARVY (bictegravir/emtricitabine/tenofovir alafenamide) from Gilead, reflecting an update…

• FDA approval · 2021-02-11
  FDA Approved: BIKTARVY — Supplemental Application (Gilead Sciences, Inc.)

  The FDA approved a supplemental NDA for BIKTARVY from Gilead Sciences, expanding or updating its labeling and/or indication.

• FDA approval · 2021-02-05
  FDA Approved: BIKTARVY — Supplemental Application (Gilead Sciences, Inc.)

  The FDA approved a supplemental application for BIKTARVY, confirming regulatory clearance for this HIV-1 treatment regimen developed by Gile…

• 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 · 2021-01-21
  FDA Approved: VOCABRIA — Original Application (ViiV Healthcare Company)

  FDA approved VOCABRIA (cabotegravir sodium) through an original drug application from ViiV Healthcare. The approval establishes cabotegravir…

• FDA approval · 2021-01-21
  FDA Approved: CABENUVA — Original Application (ViiV Healthcare Company)

  The FDA approved CABENUVA (cabotegravir and rilpivirine) as the original approval for a long-acting injectable regimen to treat HIV-1 infect…

• FDA approval · 2021-01-21
  FDA Approved: EDURANT — Supplemental Application (Janssen Products, LP)

  FDA approved a supplemental application for EDURANT (rilpivirine hydrochloride) submitted by Janssen Products, LP.

• FDA approval · 2021-01-13
  FDA Approved: EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE — Original Application (Strides Pharma Science Limited)

  FDA approved a generic fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate under an original ANDA from Strides Pharma …

• FDA approval · 2020-12-22
  FDA Approved: PREZISTA — Supplemental Application (Janssen Products LP)

  FDA approved a supplemental application for Prezista (darunavir) submitted by Janssen Products LP.

• FDA approval · 2020-12-22
  FDA Approved: PREZISTA — Supplemental Application (Janssen Products LP)

  The FDA approved a supplemental application for Prezista (darunavir) submitted by Janssen Products LP. The approval expands Prezista's label…

• FDA approval · 2020-12-22
  FDA Approved: SYMTUZA — Supplemental Application (Janssen Products LP)

  FDA approved a supplemental application for Symtuza (darunavir, cobicistat, emtricitabine, and tenofovir alafenamide) from Janssen Products …

• FDA approval · 2020-12-22
  FDA Approved: ABACAVIR, LAMIVUDINE AND ZIDOVUDINE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin's supplemental application for the fixed-dose combination Abacavir/lamivudine/zidovudine for HIV-1 infection.