HIV Infection

• FDA approval · 2014-03-27
  FDA Approved: SELZENTRY — Supplemental Application (ViiV Healthcare Company)

  FDA approved a supplemental application for Selzentry (maraviroc) submitted by ViiV Healthcare Company. The approval updates the product lab…

• FDA approval · 2014-02-20
  FDA Approved: EMTRIVA — Supplemental Application (Gilead Sciences, Inc.)

  The FDA approved a supplemental application for EMTRIVA (emtricitabine) filed by Gilead Sciences, Inc., updating the drug's labeling and/or …

• FDA approval · 2014-02-03
  FDA Approved: LAMIVUDINE AND ZIDOVUDINE — Original Application (Exelan Pharmaceuticals Inc.)

  FDA approved a generic lamivudine and zidovudine combination tablet under an original ANDA for Exelan Pharmaceuticals Inc.

• FDA approval · 2014-01-02
  FDA Approved: LAMIVUDINE — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals' generic lamivudine tablet under an Original Application (ANDA). Lamivudine is used to treat HIV-1 infec…

• FDA approval · 2014-01-02
  FDA Approved: LAMIVUDINE — Original Application (Apotex Corp.)

  FDA approves Apotex Corp.'s original application for a generic lamivudine product (ANDA 202941). The generic is approved for the same indica…

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• FDA approval · 2013-12-20
  FDA Approved: ISENTRESS — Original Application (Merck Sharp & Dohme LLC)

  The FDA approved the original application for Isentress (raltegravir) from Merck for treatment of HIV-1 infection in adults and pediatric pa…

• FDA approval · 2013-12-20
  FDA Approved: ISENTRESS — Supplemental Application (Merck Sharp & Dohme LLC)

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

• FDA approval · 2013-12-19
  FDA Approved: RETROVIR — Supplemental Application (ViiV Healthcare Company)

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

• FDA approval · 2013-12-16
  FDA Approved: TRUVADA — Supplemental Application (Gilead Sciences, Inc)

  The FDA approved a supplemental application for TRUVADA from Gilead Sciences, Inc., indicating an NDA-wide change approved via a supplementa…

• FDA approval · 2013-12-05
  FDA Approved: ABACAVIR, LAMIVUDINE AND ZIDOVUDINE — Original Application (Lupin Pharmaceuticals, Inc.)

  FDA approves Lupin Pharmaceuticals' fixed-dose combination of abacavir, lamivudine, and zidovudine (abacavir/lamivudine/zidovudine) for HIV …

• EMA approval · 2013-11-22
  European Medicines Agency recommends approval of new HIV medicine

  The European Medicines Agency recommends approval of a new HIV medicine, signaling potential market authorization pending final decision.

• FDA approval · 2013-11-08
  FDA Approved: EMTRIVA — Supplemental Application (Gilead Sciences, Inc.)

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

• FDA approval · 2013-11-08
  FDA Approved: EMTRIVA — Supplemental Application (Gilead Sciences, Inc.)

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

• FDA approval · 2013-11-08
  FDA Approved: TRUVADA — Supplemental Application (Gilead Sciences, Inc)

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

• FDA approval · 2013-11-08
  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 · 2013-11-08
  FDA Approved: STRIBILD — Supplemental Application (Gilead Sciences, Inc.)

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

• FDA approval · 2013-11-07
  FDA Approved: PREZISTA — Supplemental Application (Janssen Products LP)

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

• FDA approval · 2013-11-07
  FDA Approved: PREZISTA — Supplemental Application (Janssen Products LP)

  FDA approved a supplemental application for PREZISTA (darunavir) submitted by Janssen Products LP, representing a supplemental approval to t…

• FDA approval · 2013-11-07
  FDA Approved: KALETRA — Supplemental Application (AbbVie Inc.)

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

• FDA approval · 2013-11-07
  FDA Approved: NORVIR — Supplemental Application (AbbVie Inc.)

  FDA approved AbbVie's supplemental application for NORVIR (ritonavir).

• FDA approval · 2013-11-07
  FDA Approved: KALETRA — Supplemental Application (AbbVie Inc.)

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

• FDA approval · 2013-10-31
  FDA Approved: PREZISTA — Supplemental Application (Janssen Products LP)

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

• FDA approval · 2013-10-24
  FDA Approved: ISENTRESS — Supplemental Application (Merck Sharp & Dohme LLC)

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

• FDA approval · 2013-10-24
  FDA Approved: ISENTRESS — Supplemental Application (Merck Sharp & Dohme LLC)

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

• FDA approval · 2013-10-23
  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.