HIV Infection

• FDA approval · 2012-02-17
  FDA Approved: APTIVUS — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Aptivus (tipranavir) submitted by Boehringer Ingelheim Pharmaceuticals, Inc.

• FDA approval · 2012-02-13
  FDA Approved: PREZISTA — Supplemental Application (Janssen Products LP)

  FDA approved a supplemental application for PREZISTA (darunavir) by Janssen Products LP. The action involves a supplemental NDA approval.

• FDA approval · 2012-01-18
  FDA Approved: VIREAD — Original Application (Gilead Sciences, Inc.)

  FDA original approval of VIREAD (tenofovir disoproxil fumarate) by Gilead Sciences, Inc.

• FDA approval · 2011-12-30
  FDA Approved: ZIDOVUDINE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Zidovudine submitted by Aurobindo Pharma Limited under an ANDA, authorizing changes to the appro…

• FDA approval · 2011-12-21
  FDA Approved: ISENTRESS — Original Application (Merck Sharp & Dohme LLC)

  FDA approved ISENTRESS (raltegravir) in its original application for HIV-1 infection.

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• FDA approval · 2011-12-21
  FDA Approved: ISENTRESS — Supplemental Application (Merck Sharp & Dohme LLC)

  FDA approved a supplemental application for Isentress (raltegravir) filed by Merck Sharp & Dohme LLC, resulting in an approved change to the…

• FDA approval · 2011-12-16
  FDA Approved: PREZISTA — Original Application (Janssen Products LP)

  This document announces the original FDA approval of PREZISTA (darunavir) for HIV-1 infection.

• FDA approval · 2011-12-16
  FDA Approved: PREZISTA — Supplemental Application (Janssen Products LP)

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

• FDA approval · 2011-12-02
  FDA Approved: LAMIVUDINE — Original Application (Apotex Corp.)

  FDA approves Apotex Corp.'s original application for lamivudine (generic), authorizing its marketing for HIV-1 infection and chronic hepatit…

• FDA approval · 2011-11-18
  FDA Approved: COMBIVIR — Supplemental Application (ViiV Healthcare Company)

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

• FDA approval · 2011-11-18
  FDA Approved: RETROVIR — Supplemental Application (ViiV Healthcare Company)

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

• FDA approval · 2011-11-18
  FDA Approved: EMTRIVA — Supplemental Application (Gilead Sciences, Inc.)

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

• FDA approval · 2011-11-18
  FDA Approved: RETROVIR — Supplemental Application (ViiV Healthcare Company)

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

• FDA approval · 2011-11-18
  FDA Approved: EPIVIR — Supplemental Application (ViiV Healthcare Company)

  The FDA approved a supplemental application for EPIVIR (lamivudine) submitted by ViiV Healthcare Company, potentially updating labeling or e…

• FDA approval · 2011-11-18
  FDA Approved: EPIVIR — Supplemental Application (ViiV Healthcare Company)

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

• FDA approval · 2011-11-18
  FDA Approved: RETROVIR — Supplemental Application (ViiV Healthcare Company)

  FDA approval of a supplemental application for RETROVIR (zidovudine) filed by ViiV Healthcare Company.

• FDA approval · 2011-11-18
  FDA Approved: ZIAGEN — Supplemental Application (ViiV Healthcare Company)

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

• FDA approval · 2011-11-02
  FDA Approved: ISENTRESS — Supplemental Application (Merck Sharp & Dohme LLC)

  The FDA approved a supplemental application for ISENTRESS (raltegravir) from Merck Sharp & Dohme LLC, extending or updating its approved use…

• FDA approval · 2011-10-21
  FDA Approved: SELZENTRY — Supplemental Application (ViiV Healthcare Company)

  The FDA approved a supplemental application for SELZENTRY (maraviroc) submitted by ViiV Healthcare Company, updating the drug's labeling and…

• FDA approval · 2011-10-19
  FDA Approved: PREZISTA — Supplemental Application (Janssen Products LP)

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

• FDA approval · 2011-10-17
  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 the drug's lab…

• FDA approval · 2011-10-07
  FDA Approved: ETRAVIRINE — Supplemental Application (Patriot Pharmaceuticals)

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

• FDA approval · 2011-08-10
  FDA Approved: COMPLERA — Original Application (Gilead Sciences, Inc.)

  FDA approved COMPLERA as an Original Application (NDA 202123) for HIV-1 infection. It is a single-tablet regimen containing emtricitabine, r…

• FDA approval · 2011-07-08
  FDA Approved: TRUVADA — Supplemental Application (Gilead Sciences, Inc)

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

• FDA approval · 2011-06-10
  FDA Approved: ISENTRESS — Supplemental Application (Merck Sharp & Dohme LLC)

  The FDA approved a supplemental application for Isentress (raltegravir) by Merck Sharp & Dohme LLC.