HIV Infection

• FDA approval · 2017-08-15
  FDA Approved: GENVOYA — Supplemental Application (Gilead Sciences, Inc.)

  FDA approved a supplemental application for GENVOYA (Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir Alafenamide) from Gilead Science…

• FDA approval · 2017-06-29
  FDA Approved: NORVIR — Supplemental Application (AbbVie Inc.)

  FDA approved a supplemental application for NORVIR (ritonavir) submitted by AbbVie Inc.

• FDA approval · 2017-06-29
  FDA Approved: NORVIR — Supplemental Application (AbbVie Inc.)

  The FDA approved a supplemental application for NORVIR (ritonavir) submitted by AbbVie Inc., updating labeling for the product.

• FDA approval · 2017-06-19
  FDA Approved: PREZISTA — Supplemental Application (Janssen Products LP)

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

• FDA approval · 2017-06-19
  FDA Approved: PREZISTA — Supplemental Application (Janssen Products LP)

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

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• FDA approval · 2017-06-15
  FDA Approved: KALETRA — Supplemental Application (AbbVie Inc.)

  The FDA approved a supplemental application for KALETRA (lopinavir/ritonavir) from AbbVie Inc.

• FDA approval · 2017-06-15
  FDA Approved: KALETRA — Supplemental Application (AbbVie Inc.)

  The FDA approved a supplemental application for KALETRA (lopinavir/ritonavir) submitted by AbbVie Inc., resulting in updated labeling for th…

• FDA approval · 2017-06-14
  FDA Approved: PREZCOBIX — Supplemental Application (Janssen Products, LP)

  The FDA approved a supplemental application for PrezcoBix (darunavir ethanolate and cobicistat) from Janssen Products LP.

• FDA approval · 2017-06-08
  FDA Approved: TRUVADA — Supplemental Application (Gilead Sciences, Inc)

  FDA approved a supplemental application for Truvada (emtricitabine and tenofovir disoproxil fumarate) submitted by Gilead Sciences, Inc. The…

• FDA approval · 2017-06-08
  FDA Approved: EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE — Original Application (Teva Pharmaceuticals USA, Inc.)

  FDA approves Teva's emtricitabine and tenofovir disoproxil fumarate as an original generic application for HIV-1 infection.

• FDA approval · 2017-06-07
  FDA Approved: NORVIR — Original Application (AbbVie Inc.)

  FDA approves NORVIR (ritonavir) from AbbVie as an original application for HIV infection; Ritonavir is an antiretroviral protease inhibitor …

• FDA approval · 2017-06-07
  FDA Approved: NORVIR — Supplemental Application (AbbVie Inc.)

  FDA approved a supplemental application for NORVIR (ritonavir) by AbbVie Inc.

• FDA approval · 2017-05-26
  FDA Approved: ISENTRESS — Supplemental Application (Merck Sharp & Dohme LLC)

  The FDA approved a supplemental application for Isentress (raltegravir) from Merck Sharp & Dohme LLC, resulting in changes to its labeling u…

• FDA approval · 2017-05-26
  FDA Approved: ISENTRESS — Supplemental Application (Merck Sharp & Dohme LLC)

  The FDA approved a supplemental application for Isentress (raltegravir) submitted by Merck Sharp & Dohme LLC. The action updates the labelin…

• FDA approval · 2017-05-26
  FDA Approved: ISENTRESS — Supplemental Application (Merck Sharp & Dohme LLC)

  FDA approved a supplemental application for ISENTRESS (raltegravir) submitted by Merck Sharp & Dohme LLC.

• FDA approval · 2017-05-23
  FDA Approved: REYATAZ — Supplemental Application (E.R. Squibb & Sons, L.L.C.)

  The FDA approved a supplemental NDA for Reyataz (atazanavir) from E.R. Squibb & Sons, L.L.C., authorizing changes requested in the supplemen…

• FDA approval · 2017-05-23
  FDA Approved: REYATAZ — Supplemental Application (E.R. Squibb & Sons, L.L.C.)

  FDA approved a supplemental application for REYATAZ (atazanavir) submitted by E.R. Squibb & Sons, L.L.C., resulting in an approved supplemen…

• FDA approval · 2017-05-05
  FDA Approved: LAMIVUDINE AND ZIDOVUDINE — Original Application (Aurobindo Pharma Limited)

  FDA approved a generic combination of lamivudine and zidovudine under an Original Application from Aurobindo Pharma Limited for the treatmen…

• FDA approval · 2017-05-04
  FDA Approved: TYBOST — Supplemental Application (Gilead Sciences, Inc.)

  FDA approved a supplemental application for Tybost (cobicistat) from Gilead Sciences, authorizing changes to its labeling related to HIV tre…

• FDA approval · 2017-05-04
  FDA Approved: STRIBILD — Supplemental Application (Gilead Sciences, Inc.)

  FDA approved a supplemental application for STRIBILD, a fixed-dose combination antiretroviral therapy for HIV-1 infection from Gilead Scienc…

• FDA approval · 2017-04-21
  FDA Approved: TRUVADA — Supplemental Application (Gilead Sciences, Inc)

  FDA approved a supplemental application for TRUVADA (emtricitabine and tenofovir disoproxil fumarate) submitted by Gilead Sciences, Inc. The…

• FDA approval · 2017-04-10
  FDA Approved: RETROVIR — Supplemental Application (ViiV Healthcare Company)

  FDA approved a supplemental application for RETROVIR (zidovudine) submitted by ViiV Healthcare Company. The approval pertains to the supplem…

• FDA approval · 2017-04-10
  FDA Approved: RETROVIR — Supplemental Application (ViiV Healthcare Company)

  FDA approved a supplemental application for RETROVIR (zidovudine) submitted by ViiV Healthcare Company.

• FDA approval · 2017-04-10
  FDA Approved: RETROVIR — Supplemental Application (ViiV Healthcare Company)

  FDA approved a supplemental application for RETROVIR (zidovudine) submitted by ViiV Healthcare Company.

• FDA approval · 2017-04-10
  FDA Approved: COMBIVIR — Supplemental Application (ViiV Healthcare Company)

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