HIV Infection

• FDA approval · 2019-06-18
  FDA Approved: BIKTARVY — Supplemental Application (Gilead Sciences, Inc.)

  The FDA approved a supplemental application for BIKTARVY from Gilead Sciences.

• FDA approval · 2019-06-03
  FDA Approved: EFAVIRENZ, EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE — Original Application (Cipla USA Inc.)

  The FDA approved Cipla USA Inc.'s original-application generic product of efavirenz, emtricitabine, and tenofovir disoproxil fumarate for HI…

• FDA approval · 2019-05-30
  FDA Approved: SYMTUZA — Supplemental Application (Janssen Products LP)

  FDA approved a supplemental application for SYMTUZA (darunavir/cobicistat/emtricitabine/tenofovir alafenamide) submitted by Janssen Products…

• FDA approval · 2019-05-28
  FDA Approved: PREZISTA — Supplemental Application (Janssen Products LP)

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

• FDA approval · 2019-05-14
  FDA Approved: EDURANT — Supplemental Application (Janssen Products, LP)

  FDA approved a supplemental application for EDURANT (rilpivirine hydrochloride) from Janssen, updating the product's approval.

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

  The FDA approved a supplemental application for Combivir (lamivudine and zidovudine) by ViiV Healthcare Company.

• FDA approval · 2019-05-03
  FDA Approved: TRIUMEQ — Supplemental Application (ViiV Healthcare Company)

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

• FDA approval · 2019-05-01
  FDA Approved: LAMIVUDINE — Original Application (Macleods Pharmaceuticals Limited)

  FDA approved Macleods Pharmaceuticals Limited's original application for lamivudine (generic). Lamivudine is used in combination therapy for…

• FDA approval · 2019-04-08
  FDA Approved: DOVATO — Original Application (ViiV Healthcare Company)

  The FDA approved Dovato, a fixed-dose combination of dolutegravir and lamivudine, under an original NDA for the treatment of HIV-1 infection…

• FDA approval · 2019-03-21
  FDA Approved: PREZISTA — Supplemental Application (Janssen Products LP)

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

• FDA approval · 2019-03-21
  FDA Approved: PREZISTA — Supplemental Application (Janssen Products LP)

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

• FDA approval · 2019-03-21
  FDA Approved: LAMIVUDINE — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approves Camber Pharmaceuticals' generic lamivudine as an original generic application for HIV-1 infection and chronic hepatitis B. This…

• FDA approval · 2019-03-18
  FDA Approved: GENVOYA — Supplemental Application (Gilead Sciences, Inc.)

  FDA approved a supplemental application for GENVOYA (elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide).

• FDA approval · 2019-02-25
  FDA Approved: SYMTUZA — Supplemental Application (Janssen Products LP)

  The FDA approved a supplemental application for SYMTUZA (darunavir, cobicistat, emtricitabine, and tenofovir alafenamide) from Janssen Produ…

• FDA approval · 2019-02-06
  FDA Approved: STRIBILD — Supplemental Application (Gilead Sciences, Inc.)

  FDA approved a supplemental application for STRIBILD (elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate) from Gilea…

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

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

• FDA approval · 2019-01-28
  FDA Approved: PREZCOBIX — Supplemental Application (Janssen Products, LP)

  FDA approved a supplemental application for PREZCOBIX (darunavir ethanolate and cobicistat) filed by Janssen Products, LP.

• FDA approval · 2019-01-25
  FDA Approved: SYMTUZA — Supplemental Application (Janssen Products LP)

  The FDA approved a supplemental application for SYMTUZA (darunavir/cobicistat/emtricitabine/tenofovir alafenamide) submitted by Janssen Prod…

• FDA approval · 2019-01-14
  FDA Approved: NEVIRAPINE — Original Application (Macleods Pharmaceuticals Limited)

  FDA approves the original generic application for Nevirapine from Macleods Pharmaceuticals Limited for treatment of HIV infection.

• 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.

• FDA approval · 2018-12-10
  FDA Approved: EMTRIVA — Supplemental Application (Gilead Sciences, Inc.)

  FDA approved a supplemental application for EMTRIVA (emtricitabine) from Gilead Sciences, resulting in a labeling update or expanded use und…

• FDA approval · 2018-12-10
  FDA Approved: EMTRIVA — Supplemental Application (Gilead Sciences, Inc.)

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

• FDA approval · 2018-11-15
  FDA Approved: KALETRA — Supplemental Application (AbbVie Inc.)

  The FDA issued a supplemental approval for Kaletra (lopinavir/ritonavir) submitted by AbbVie.

• FDA approval · 2018-11-15
  FDA Approved: NORVIR — Supplemental Application (AbbVie Inc.)

  FDA approved a supplemental application for Norvir (ritonavir) submitted by AbbVie. The approval updates the product under the NDA, potentia…