HIV Infection

• FDA approval · 2008-10-03
  FDA Approved: KALETRA — Supplemental Application (AbbVie Inc.)

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

• FDA approval · 2008-10-03
  FDA Approved: KALETRA — Supplemental Application (AbbVie Inc.)

  The FDA approved a supplemental application for KALETRA (lopinavir/ritonavir) from AbbVie. The approval updates the product's labeling or in…

• FDA approval · 2008-09-30
  FDA Approved: REYATAZ — Supplemental Application (E.R. Squibb & Sons, L.L.C.)

  FDA approved a supplemental application for Reyataz (atazanavir) filed by E.R. Squibb & Sons, L.L.C.

• FDA approval · 2008-09-19
  FDA Approved: RETROVIR — Supplemental Application (ViiV Healthcare Company)

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

• FDA approval · 2008-09-19
  FDA Approved: RETROVIR — Supplemental Application (ViiV Healthcare Company)

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

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• FDA approval · 2008-08-15
  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 changes approved to t…

• FDA approval · 2008-07-18
  FDA Approved: ZIAGEN — Supplemental Application (ViiV Healthcare Company)

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

• FDA approval · 2008-06-23
  FDA Approved: APTIVUS — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Aptivus (tipranavir) from Boehringer Ingelheim Pharmaceuticals, Inc. The action updates Apti…

• FDA approval · 2008-06-20
  FDA Approved: KALETRA — Supplemental Application (AbbVie Inc.)

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

• FDA approval · 2008-06-20
  FDA Approved: KALETRA — Supplemental Application (AbbVie Inc.)

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

• FDA approval · 2008-06-09
  FDA Approved: ZIDOVUDINE — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for Zidovudine filed by Aurobindo Pharma Limited, enabling continued marketing of the generic dr…

• FDA approval · 2008-06-09
  FDA Approved: ZIDOVUDINE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approves a supplemental ANDA for Zidovudine by Aurobindo Pharma Limited, authorizing the generic Zidovudine product.

• FDA approval · 2008-06-09
  FDA Approved: ZIDOVUDINE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Zidovudine by Aurobindo Pharma Limited, authorizing a generic Zidovudine product. This approval …

• FDA approval · 2008-05-16
  FDA Approved: EMTRIVA — Supplemental Application (Gilead Sciences, Inc.)

  The FDA approved a supplemental application for Emtriva (emtricitabine) from Gilead Sciences, Inc., resulting in an updated approval/label f…

• FDA approval · 2008-05-16
  FDA Approved: VIREAD — Supplemental Application (Gilead Sciences, Inc.)

  The FDA approved a supplemental application for Viread (tenofovir disoproxil fumarate) from Gilead Sciences, Inc. The approval updates the p…

• FDA approval · 2008-04-25
  FDA Approved: ZIDOVUDINE — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approval of Camber Pharmaceuticals' generic Zidovudine under an original application for HIV infection treatment.

• FDA approval · 2008-03-25
  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. The action updates Reyataz unde…

• FDA approval · 2008-02-25
  FDA Approved: PREZISTA — Supplemental Application (Janssen Products LP)

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

• FDA approval · 2008-02-13
  FDA Approved: VIRACEPT — Supplemental Application (AGOURON)

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

• FDA approval · 2008-02-13
  FDA Approved: VIRACEPT — Supplemental Application (AGOURON)

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

• FDA approval · 2008-02-01
  FDA Approved: EPIVIR — Supplemental Application (ViiV Healthcare Company)

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

• FDA approval · 2008-01-18
  FDA Approved: ETRAVIRINE — Original Application (Patriot Pharmaceuticals)

  Etravirine received FDA approval as an original drug application for the treatment of HIV-1 infection in treatment-experienced adults, to be…

• FDA approval · 2007-12-21
  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., supporting changes to the product’s labeling a…

• FDA approval · 2007-11-09
  FDA Approved: KALETRA — Supplemental Application (AbbVie Inc.)

  FDA approved a supplemental application for KALETRA (lopinavir/ritonavir) from AbbVie Inc. The action reflects approval of a supplemental ND…

• FDA approval · 2007-10-12
  FDA Approved: ISENTRESS — Original Application (Merck Sharp & Dohme LLC)

  FDA approval of Isentress (raltegravir) through the original application for the treatment of HIV-1 infection in combination with other anti…