HIV Infection

• FDA approval · 2020-06-12
  FDA Approved: TIVICAY PD — Original Application (ViiV Healthcare Company)

  FDA approved Tivicay PD (dolutegravir sodium) under an original application for HIV-1 infection, introducing a new product formulation of do…

• FDA approval · 2020-06-12
  FDA Approved: TIVICAY — Supplemental Application (ViiV Healthcare Company)

  FDA approved a supplemental application for TIVICAY (dolutegravir) from ViiV Healthcare Company, resulting in updated labeling per the suppl…

• FDA approval · 2020-06-11
  FDA Approved: ZIDOVUDINE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Zidovudine (AZT) by Aurobindo Pharma Limited. This approval supports a generic Zidovudine produc…

• 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 · 2020-05-15
  FDA Approved: EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE — Original Application (Macleods Pharmaceuticals Limited)

  FDA approved the original application for a generic fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate (FTC/TDF). The…

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• FDA approval · 2020-05-14
  FDA Approved: EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE — Original Application (Laurus Labs Limited)

  FDA approved Laurus Labs' generic fixed-dose combination efavirenz, lamivudine, and tenofovir disoproxil fumarate for HIV-1 infection.

• FDA approval · 2020-05-14
  FDA Approved: EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE — Original Application (Laurus Labs Limited)

  FDA approved Laurus Labs Limited's ANDA for a generic fixed-dose combination of efavirenz, lamivudine, and tenofovir disoproxil fumarate for…

• FDA approval · 2020-04-22
  FDA Approved: EVOTAZ — Supplemental Application (E.R. Squibb & Sons, L.L.C.)

  The FDA approved a supplemental application for EVOTAZ (atazanavir/cobicistat) submitted by E.R. Squibb & Sons, L.L.C.

• FDA approval · 2020-04-17
  FDA Approved: TROGARZO — Supplemental Application (Theratechnologies Inc.)

  The FDA approved a supplemental Biologics License Application for TROGARZO (ibalizumab) from Theratechnologies Inc.

• FDA approval · 2020-04-08
  FDA Approved: ZIDOVUDINE — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a Zidovudine supplemental application submitted by Aurobindo Pharma Limited. This action updates Zidovudine's approval unde…

• FDA approval · 2020-03-24
  FDA Approved: TIVICAY — Supplemental Application (ViiV Healthcare Company)

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

• FDA approval · 2020-03-24
  FDA Approved: DOVATO — Supplemental Application (ViiV Healthcare Company)

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

• FDA approval · 2020-03-24
  FDA Approved: TRIUMEQ — Supplemental Application (ViiV Healthcare Company)

  FDA approved a supplemental application for TRIUMEQ, a fixed-dose combination of abacavir, dolutegravir, and lamivudine, submitted by ViiV H…

• FDA approval · 2020-03-02
  FDA Approved: SYMTUZA — Supplemental Application (Janssen Products LP)

  FDA approved Janssen's supplemental application for Symtuza (darunavir, cobicistat, emtricitabine, and tenofovir alafenamide), resulting in …

• FDA approval · 2020-02-28
  FDA Approved: EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE — Original Application (Zydus Pharmaceuticals USA Inc.)

  FDA approved a generic fixed-dose combination tablet of emtricitabine and tenofovir disoproxil fumarate (FTC/TDF) from Zydus Pharmaceuticals…

• FDA approval · 2020-02-24
  FDA Approved: ABACAVIR AND LAMIVUDINE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' supplemental application for a generic fixed-dose combination tablet of abacavir and lamivudine for HIV …

• FDA approval · 2020-02-10
  FDA Approved: ZIDOVUDINE — Supplemental Application (Camber Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Zidovudine from Camber Pharmaceuticals, Inc., updating/expanding its approved use or labelin…

• FDA approval · 2020-02-10
  FDA Approved: ZIDOVUDINE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Zidovudine manufactured by Aurobindo Pharma Limited.

• FDA approval · 2020-02-07
  FDA Approved: DRONABINOL — Original Application (Camber Pharmaceuticals Inc)

  FDA approves Camber Pharmaceuticals' original abbreviated new drug application for dronabinol (generic). The product is indicated for chemot…

• FDA approval · 2020-02-04
  FDA Approved: EFAVIRENZ — Supplemental Application (Aurobindo Pharma Limited)

  FDA granted approval of a supplemental application for efavirenz from Aurobindo Pharma Limited, authorizing its continued generic use and po…

• FDA approval · 2020-02-04
  FDA Approved: EFAVIRENZ — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Efavirenz by Aurobindo Pharma Limited, updating the product’s approval status for the treatment …

• FDA approval · 2020-01-27
  FDA Approved: EFAVIRENZ, EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for a generic fixed-dose combination of efavirenz, emtricitabine, and tenofovir disoproxil fumarate …

• 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 · 2020-01-22
  FDA Approved: EMTRICITABINE — Supplemental Application (Cipla USA Inc.)

  FDA approves Cipla USA Inc.'s supplemental application for emtricitabine, a generic antiretroviral, finalizing changes to the product's appr…

• FDA approval · 2020-01-14
  FDA Approved: EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE — Supplemental Application (QUALLENT PHARMACEUTICALS HEALTH LLC)

  FDA approved a supplemental application for emtricitabine and tenofovir disoproxil fumarate from Quallent Pharmaceuticals Health LLC.