HIV Infection

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

  FDA approved a supplemental application for Zidovudine from Aurobindo Pharma Limited (AP). The approval confirms the availability of a gener…

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

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

• FDA approval · 2015-06-16
  FDA Approved: NEVIRAPINE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for NEVIRAPINE by Aurobindo Pharma Limited under an ANDA.

• FDA approval · 2015-06-15
  FDA Approved: TRIUMEQ — Supplemental Application (ViiV Healthcare Company)

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

• FDA approval · 2015-06-08
  FDA Approved: STRIBILD — Supplemental Application (Gilead Sciences, Inc.)

  The FDA approved a supplemental application for STRIBILD (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate) from Gilead S…

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• FDA approval · 2015-05-29
  FDA Approved: VIREAD — Supplemental Application (Gilead Sciences, Inc.)

  FDA approved a supplemental application for VIREAD (tenofovir disoproxil fumarate) submitted by Gilead Sciences, Inc. The action indicates a…

• FDA approval · 2015-05-27
  FDA Approved: PREZISTA — Supplemental Application (Janssen Products LP)

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

• FDA approval · 2015-05-27
  FDA Approved: PREZISTA — Supplemental Application (Janssen Products LP)

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

• FDA approval · 2015-05-06
  FDA Approved: ETRAVIRINE — Supplemental Application (Patriot Pharmaceuticals)

  FDA approved a supplemental application for etravirine submitted by Patriot Pharmaceuticals.

• FDA approval · 2015-05-05
  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 · 2015-05-05
  FDA Approved: EDURANT — Supplemental Application (Janssen Products, LP)

  FDA entry documenting a supplemental application for Edurant (rilpivirine hydrochloride) from Janssen Products, LP.

• FDA approval · 2015-04-21
  FDA Approved: SELZENTRY — Supplemental Application (ViiV Healthcare Company)

  The FDA approved a supplemental application for Selzentry (maraviroc) submitted by ViiV Healthcare Company.

• FDA approval · 2015-04-17
  FDA Approved: TYBOST — Supplemental Application (Gilead Sciences, Inc.)

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

• FDA approval · 2015-04-15
  FDA Approved: TYBOST — Supplemental Application (Gilead Sciences, Inc.)

  The FDA approved a supplemental application for TYBOST (cobicistat) submitted by Gilead Sciences, expanding its label for use in HIV treatme…

• FDA approval · 2015-04-07
  FDA Approved: STRIBILD — Supplemental Application (Gilead Sciences, Inc.)

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

• FDA approval · 2015-03-27
  FDA Approved: KALETRA — Supplemental Application (AbbVie Inc.)

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

• FDA approval · 2015-03-27
  FDA Approved: APTIVUS — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for APTIVUS (tipranavir) from Boehringer Ingelheim Pharmaceuticals, Inc.

• FDA approval · 2015-03-27
  FDA Approved: VIRACEPT — Supplemental Application (AGOURON)

  FDA approved a supplemental application for Viracept (nelfinavir mesylate) by Agouron, authorizing changes to the approved product labeling.

• FDA approval · 2015-03-27
  FDA Approved: VIRACEPT — Supplemental Application (AGOURON)

  The FDA approved a supplemental application for VIRACEPT (nelfinavir mesylate) submitted by Agouron.

• FDA approval · 2015-03-27
  FDA Approved: KALETRA — Supplemental Application (AbbVie Inc.)

  The FDA approved a supplemental application for KALETRA (lopinavir/ritonavir) from AbbVie Inc. to modify the drug's labeling or indications …

• FDA approval · 2015-03-27
  FDA Approved: NORVIR — Supplemental Application (AbbVie Inc.)

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

• FDA approval · 2015-03-27
  FDA Approved: PREZISTA — Supplemental Application (Janssen Products LP)

  The FDA approved a supplemental application for Prezista (darunavir) from Janssen Products LP, resulting in updated labeling for the drug.

• FDA approval · 2015-03-27
  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.

• FDA approval · 2015-03-27
  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. This action typically updates l…

• FDA approval · 2015-03-23
  FDA Approved: ZIAGEN — Supplemental Application (ViiV Healthcare Company)

  The FDA approved a supplemental application for ZIAGEN (abacavir sulfate) submitted by ViiV Healthcare Company.