HIV Infection

• FDA approval · 2016-02-09
  FDA Approved: COMPLERA — Supplemental Application (Gilead Sciences, Inc.)

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

• FDA approval · 2016-01-25
  FDA Approved: ABACAVIR — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Abacavir from Aurobindo Pharma Limited.

• FDA approval · 2015-12-29
  FDA Approved: COMPLERA — Supplemental Application (Gilead Sciences, Inc.)

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

• FDA approval · 2015-12-22
  FDA Approved: ABACAVIR AND LAMIVUDINE — Supplemental Application (Camber Pharmaceuticals, Inc.)

  The FDA approves Camber Pharmaceuticals' supplemental application for a generic abacavir/lamivudine combination product for HIV-1 infection.

• FDA approval · 2015-12-11
  FDA Approved: ZIDOVUDINE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Zidovudine submitted by Aurobindo Pharma Limited. The approval confirms continued authorization …

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• FDA approval · 2015-12-11
  FDA Approved: ABACAVIR SULFATE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for Abacavir Sulfate from Mylan Pharmaceuticals Inc.

• FDA approval · 2015-12-02
  FDA Approved: KALETRA — Supplemental Application (AbbVie Inc.)

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

• FDA approval · 2015-11-25
  FDA Approved: TYBOST — Supplemental Application (Gilead Sciences, Inc.)

  FDA approves a supplemental application for TYBOST (cobicistat) submitted by Gilead Sciences, Inc. The action represents an official regulat…

• FDA approval · 2015-11-10
  FDA Approved: KALETRA — Supplemental Application (AbbVie Inc.)

  FDA approves a supplemental application for Kaletra (lopinavir/ritonavir) by AbbVie.

• FDA approval · 2015-11-10
  FDA Approved: KALETRA — Supplemental Application (AbbVie Inc.)

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

• FDA approval · 2015-11-10
  FDA Approved: NORVIR — Supplemental Application (AbbVie Inc.)

  The FDA approved AbbVie's supplemental application for NORVIR (ritonavir).

• FDA approval · 2015-11-05
  FDA Approved: GENVOYA — Original Application (Gilead Sciences, Inc.)

  FDA approved GENVOYA as a new fixed-dose combination tablet for HIV-1 infection, combining elvitegravir, cobicistat, emtricitabine, and teno…

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

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

• FDA approval · 2015-09-28
  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 · 2015-09-25
  FDA Approved: COMBIVIR — Supplemental Application (ViiV Healthcare Company)

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

• FDA approval · 2015-09-24
  FDA Approved: REYATAZ — Supplemental Application (E.R. Squibb & Sons, L.L.C.)

  The FDA approved a supplemental application for Reyataz (atazanavir) from E.R. Squibb & Sons, L.L.C., resulting in changes to its labeling.

• FDA approval · 2015-09-24
  FDA Approved: REYATAZ — Supplemental Application (E.R. Squibb & Sons, L.L.C.)

  The FDA approved a supplemental application for Reyataz (atazanavir) submitted by E.R. Squibb & Sons, L.L.C., marking an approved regulatory…

• FDA approval · 2015-09-17
  FDA Approved: LAMIVUDINE AND ZIDOVUDINE — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals' lamivudine and zidovudine as an original application, a generic fixed-dose combination for HIV-1 infect…

• FDA approval · 2015-08-10
  FDA Approved: STRIBILD — Supplemental Application (Gilead Sciences, Inc.)

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

• FDA approval · 2015-08-05
  FDA Approved: TRIUMEQ — Supplemental Application (ViiV Healthcare Company)

  FDA approved a supplemental application for TRIUMEQ (abacavir sulfate, dolutegravir sodium, lamivudine) submitted by ViiV Healthcare. The ac…

• FDA approval · 2015-08-05
  FDA Approved: TIVICAY — Supplemental Application (ViiV Healthcare Company)

  FDA approves a supplemental application for Tivicay (dolutegravir) submitted by ViiV Healthcare Company.

• FDA approval · 2015-07-30
  FDA Approved: TIVICAY — Supplemental Application (ViiV Healthcare Company)

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

• FDA approval · 2015-07-23
  FDA Approved: EVOTAZ — Supplemental Application (E.R. Squibb & Sons, L.L.C.)

  The FDA approved a supplemental application for Evotaz (atazanavir and cobicistat) submitted by E.R. Squibb & Sons, L.L.C., in connection wi…

• FDA approval · 2015-06-26
  FDA Approved: KALETRA — Supplemental Application (AbbVie Inc.)

  The FDA approved a supplemental application for KALETRA (lopinavir–ritonavir) from AbbVie Inc. The action relates to the KALETRA product as …

• FDA approval · 2015-06-26
  FDA Approved: ZIDOVUDINE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Zidovudine from Aurobindo Pharma Limited, authorizing changes to the generic Zidovudine product …