HIV Infection

• FDA approval · 2014-10-31
  FDA Approved: LAMIVUDINE — Original Application (Chartwell RX, LLC)

  FDA approved the Original Application for Lamivudine oral from Chartwell RX, LLC, a generic lamivudine product. Indications include treatmen…

• FDA approval · 2014-10-27
  FDA Approved: NEVIRAPINE — Original Application (Mylan Pharmaceuticals Inc.)

  FDA approved the original application for Nevirapine from Mylan Pharmaceuticals Inc., enabling the marketing of a generic version of the dru…

• FDA approval · 2014-10-10
  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 · 2014-09-24
  FDA Approved: TYBOST — Original Application (Gilead Sciences, Inc.)

  Tybost (cobicistat) received FDA approval as an original application from Gilead Sciences; cobicistat is a pharmacokinetic booster used in H…

• FDA approval · 2014-09-16
  FDA Approved: COMPLERA — Supplemental Application (Gilead Sciences, Inc.)

  FDA approved a supplemental application for COMPLERA (emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil fumarate) from Gile…

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• FDA approval · 2014-08-29
  FDA Approved: TIVICAY — Supplemental Application (ViiV Healthcare Company)

  The FDA approved a supplemental application for Tivicay (dolutegravir sodium) submitted by ViiV Healthcare Company. This action approves a s…

• FDA approval · 2014-08-28
  FDA Approved: STRIBILD — Supplemental Application (Gilead Sciences, Inc.)

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

• FDA approval · 2014-08-22
  FDA Approved: TRIUMEQ — Original Application (ViiV Healthcare Company)

  FDA approved Triumeq (abacavir sulfate, dolutegravir sodium, lamivudine) through its original application; it is a fixed-dose combination an…

• FDA approval · 2014-08-20
  FDA Approved: ETRAVIRINE — Supplemental Application (Patriot Pharmaceuticals)

  FDA approved a supplemental application for etravirine by Patriot Pharmaceuticals.

• FDA approval · 2014-07-11
  FDA Approved: TRUVADA — Supplemental Application (Gilead Sciences, Inc)

  The FDA approved a supplemental application for TRUVADA (emtricitabine/tenofovir disoproxil fumarate) to update/expand its labeling.

• FDA approval · 2014-06-18
  FDA Approved: TRUVADA — Supplemental Application (Gilead Sciences, Inc)

  FDA approved a supplemental application for Truvada (emtricitabine/tenofovir disoproxil fumarate) filed by Gilead Sciences, Inc.

• FDA approval · 2014-06-05
  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 · 2014-06-02
  FDA Approved: REYATAZ — Original Application (E.R. Squibb & Sons, L.L.C.)

  FDA approves REYATAZ (atazanavir) under its original NDA filed by E.R. Squibb & Sons, L.L.C. for the treatment of HIV-1 infection.

• FDA approval · 2014-05-12
  FDA Approved: TIVICAY — Supplemental Application (ViiV Healthcare Company)

  The FDA has approved a supplemental application for Tivicay (dolutegravir) submitted by ViiV Healthcare Company.

• FDA approval · 2014-05-08
  FDA Approved: PREZISTA — Supplemental Application (Janssen Products LP)

  The FDA approved a supplemental application for Prezista (darunavir) by Janssen Products LP, resulting in an expanded regulatory approval.

• FDA approval · 2014-05-08
  FDA Approved: PREZISTA — Supplemental Application (Janssen Products LP)

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

• FDA approval · 2014-05-01
  FDA Approved: EDURANT — Supplemental Application (Janssen Products, LP)

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

• FDA approval · 2014-04-22
  FDA Approved: ATAZANAVIR SULFATE — Original Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved an original ANDA for atazanavir sulfate (generic), manufactured by Teva Pharmaceuticals USA, Inc., for the treatment of HIV…

• FDA approval · 2014-04-14
  FDA Approved: SELZENTRY — Supplemental Application (ViiV Healthcare Company)

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

• FDA approval · 2014-04-08
  FDA Approved: ISENTRESS — Supplemental Application (Merck Sharp & Dohme LLC)

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

• FDA approval · 2014-04-08
  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 · 2014-04-08
  FDA Approved: ISENTRESS — Supplemental Application (Merck Sharp & Dohme LLC)

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

• FDA approval · 2014-04-07
  FDA Approved: PREZISTA — Supplemental Application (Janssen Products LP)

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

• FDA approval · 2014-04-07
  FDA Approved: APTIVUS — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

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

• FDA approval · 2014-04-07
  FDA Approved: PREZISTA — Supplemental Application (Janssen Products LP)

  FDA approved a supplemental application for PREZISTA (darunavir) from Janssen Products LP, resulting in updated labeling for the HIV-1 prote…