HIV Infection

• FDA approval · 2010-05-27
  FDA Approved: SELZENTRY — Supplemental Application (ViiV Healthcare Company)

  The FDA approved a supplemental application for SELZENTRY (maraviroc) filed by ViiV Healthcare Company.

• FDA approval · 2010-05-17
  FDA Approved: RETROVIR — Supplemental Application (ViiV Healthcare Company)

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

• FDA approval · 2010-05-17
  FDA Approved: RETROVIR — Supplemental Application (ViiV Healthcare Company)

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

• FDA approval · 2010-04-27
  FDA Approved: KALETRA — Supplemental Application (AbbVie Inc.)

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

• FDA approval · 2010-04-27
  FDA Approved: KALETRA — Supplemental Application (AbbVie Inc.)

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

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• FDA approval · 2010-04-27
  FDA Approved: APTIVUS — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for APTIVUS (tipranavir) submitted by Boehringer Ingelheim Pharmaceuticals, indicating additiona…

• FDA approval · 2010-04-26
  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., approving changes to the existing …

• FDA approval · 2010-04-26
  FDA Approved: VIRACEPT — Supplemental Application (AGOURON)

  FDA approved a supplemental application for Viracept (nelfinavir mesylate) submitted by Agouron, to the existing NDA NDA020779.

• FDA approval · 2010-04-26
  FDA Approved: PREZISTA — Supplemental Application (Janssen Products LP)

  The FDA approved a supplemental application for PREZISTA (darunavir) submitted by Janssen Products LP, updating the labeling as part of the …

• FDA approval · 2010-04-26
  FDA Approved: VIRACEPT — Supplemental Application (AGOURON)

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

• FDA approval · 2010-03-26
  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 · 2010-03-24
  FDA Approved: VIREAD — Supplemental Application (Gilead Sciences, Inc.)

  FDA approved a supplemental application for VIREAD (tenofovir disoproxil fumarate) from Gilead Sciences, Inc.

• FDA approval · 2010-02-25
  FDA Approved: ZIDOVUDINE — Supplemental Application (Camber Pharmaceuticals, Inc.)

  FDA approved a supplemental application for zidovudine submitted by Camber Pharmaceuticals, Inc. This approval authorizes the changes reques…

• FDA approval · 2010-02-23
  FDA Approved: ETRAVIRINE — Supplemental Application (Patriot Pharmaceuticals)

  The FDA approved a supplemental application for etravirine filed by Patriot Pharmaceuticals.

• FDA approval · 2010-02-10
  FDA Approved: NORVIR — Original Application (AbbVie Inc.)

  FDA approved NORVIR (ritonavir) under its original application with AbbVie, establishing ritonavir's use as part of antiretroviral therapy f…

• FDA approval · 2010-01-29
  FDA Approved: KALETRA — Supplemental Application (AbbVie Inc.)

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

• FDA approval · 2010-01-29
  FDA Approved: KALETRA — Supplemental Application (AbbVie Inc.)

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

• FDA approval · 2010-01-27
  FDA Approved: PREZISTA — Supplemental Application (Janssen Products LP)

  The FDA approved a supplemental application for Prezista (darunavir) from Janssen Products LP. The action updates the labeling/indication fo…

• FDA approval · 2010-01-22
  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., approving the sponsor's requested chan…

• FDA approval · 2010-01-15
  FDA Approved: TRUVADA — Supplemental Application (Gilead Sciences, Inc)

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

• FDA approval · 2009-11-24
  FDA Approved: ETRAVIRINE — Supplemental Application (Patriot Pharmaceuticals)

  The FDA approved a supplemental application for etravirine (ETRAVIRINE) submitted by Patriot Pharmaceuticals. This action updates labeling t…

• FDA approval · 2009-11-20
  FDA Approved: SELZENTRY — Supplemental Application (ViiV Healthcare Company)

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

• FDA approval · 2009-11-10
  FDA Approved: VIREAD — Supplemental Application (Gilead Sciences, Inc.)

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

• FDA approval · 2009-11-06
  FDA Approved: RETROVIR — Supplemental Application (ViiV Healthcare Company)

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

• FDA approval · 2009-11-06
  FDA Approved: RETROVIR — Supplemental Application (ViiV Healthcare Company)

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