HIV Infection

• FDA approval · 2012-12-07
  FDA Approved: EDURANT — Supplemental Application (Janssen Products, LP)

  FDA approved a supplemental application for EDURANT (rilpivirine hydrochloride) by Janssen Products, LP.

• FDA approval · 2012-11-30
  FDA Approved: KALETRA — Supplemental Application (AbbVie Inc.)

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

• FDA approval · 2012-11-20
  FDA Approved: NORVIR — Supplemental Application (AbbVie Inc.)

  The FDA approved AbbVie’s supplemental application for Norvir (ritonavir). The approval updates the product’s labeling and/or approved use f…

• FDA approval · 2012-11-09
  FDA Approved: PREZISTA — Supplemental Application (Janssen Products LP)

  FDA approved a supplemental application for Prezista (darunavir) submitted by Janssen Products LP, resulting in an updated labeling for the …

• FDA approval · 2012-10-30
  FDA Approved: ZIDOVUDINE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approves Zidovudine under a supplemental application filed by Aurobindo Pharma Limited.

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• FDA approval · 2012-10-30
  FDA Approved: ZIDOVUDINE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Zidovudine (AZT) from Aurobindo Pharma Limited under an ANDA.

• FDA approval · 2012-09-14
  FDA Approved: NEVIRAPINE — Supplemental Application (Camber Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for NEVIRAPINE submitted by Camber Pharmaceuticals, Inc.

• FDA approval · 2012-08-27
  FDA Approved: STRIBILD — Original Application (Gilead Sciences, Inc.)

  FDA approved STRIBILD (elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate) as a single-tablet regimen for the treatm…

• FDA approval · 2012-08-10
  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 · 2012-08-10
  FDA Approved: SELZENTRY — Supplemental Application (ViiV Healthcare Company)

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

• FDA approval · 2012-08-10
  FDA Approved: EDURANT — Supplemental Application (Janssen Products, LP)

  The FDA approved a supplemental application for Edurant (rilpivirine hydrochloride) submitted by Janssen Products, LP, reflecting an FDA reg…

• FDA approval · 2012-08-10
  FDA Approved: ETRAVIRINE — Supplemental Application (Patriot Pharmaceuticals)

  The FDA approved a supplemental application for etravirine filed by Patriot Pharmaceuticals, updating the drug's labeling for HIV-1 infectio…

• FDA approval · 2012-08-07
  FDA Approved: VIREAD — Supplemental Application (Gilead Sciences, Inc.)

  The FDA approved a supplemental application for Viread (tenofovir disoproxil fumarate) submitted by Gilead Sciences, Inc., resulting in chan…

• FDA approval · 2012-08-07
  FDA Approved: VIREAD — Supplemental Application (Gilead Sciences, Inc.)

  The FDA approved a supplemental application for VIREAD (tenofovir disoproxil fumarate) submitted by Gilead Sciences, Inc. to update or expan…

• FDA approval · 2012-08-01
  FDA Approved: ZIDOVUDINE — Supplemental Application (Aurobindo Pharma Limited)

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

• FDA approval · 2012-07-23
  FDA Approved: EMTRIVA — Supplemental Application (Gilead Sciences, Inc.)

  FDA approved a supplemental application for Emtriva (emtricitabine) by Gilead Sciences.

• FDA approval · 2012-07-23
  FDA Approved: EMTRIVA — Supplemental Application (Gilead Sciences, Inc.)

  The FDA approved a supplemental application for EMTRIVA (emtricitabine) filed by Gilead Sciences.

• FDA approval · 2012-06-18
  FDA Approved: ABACAVIR SULFATE — Original Application (Mylan Pharmaceuticals Inc.)

  FDA approved the Original Application for Abacavir sulfate from Mylan Pharmaceuticals Inc., providing a generic version of abacavir sulfate …

• FDA approval · 2012-06-01
  FDA Approved: PREZISTA — Supplemental Application (Janssen Products LP)

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

• FDA approval · 2012-06-01
  FDA Approved: PREZISTA — Supplemental Application (Janssen Products LP)

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

• FDA approval · 2012-05-31
  FDA Approved: RETROVIR — Supplemental Application (ViiV Healthcare Company)

  The FDA approved a supplemental application for Retrovir (zidovudine) from ViiV Healthcare Company, updating the existing approval for Zidov…

• FDA approval · 2012-05-31
  FDA Approved: RETROVIR — Supplemental Application (ViiV Healthcare Company)

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

• FDA approval · 2012-05-22
  FDA Approved: NEVIRAPINE — Original Application (Micro Labs Limited)

  FDA approved Nevirapine from Micro Labs Limited under an Original Application (ANDA) for the generic product. The approval confirms the gene…

• FDA approval · 2012-05-22
  FDA Approved: NEVIRAPINE — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals' original ANDA for nevirapine (generic) as an antiretroviral for HIV-1 infection.

• FDA approval · 2012-05-22
  FDA Approved: NEVIRAPINE — Original Application (Mylan Pharmaceuticals Inc.)

  FDA approved Mylan Pharmaceuticals' original application for Nevirapine as a generic treatment for HIV-1 infection.