HIV Infection

• FDA approval · 2018-08-22
  FDA Approved: EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE — Original Application (Amneal Pharmaceuticals NY LLC)

  FDA approved Amneal Pharmaceuticals' generic fixed-dose combination emtricitabine and tenofovir disoproxil fumarate (FTC/TDF) for treatment …

• FDA approval · 2018-08-07
  FDA Approved: STRIBILD — Supplemental Application (Gilead Sciences, Inc.)

  The FDA approved a supplemental application for STRIBILD, a fixed-dose combination HIV-1 therapy manufactured by Gilead Sciences, Inc.

• FDA approval · 2018-08-01
  FDA Approved: GENVOYA — Supplemental Application (Gilead Sciences, Inc.)

  FDA approved a supplemental application for GENVOYA, the fixed-dose combination tablet of elvitegravir, cobicistat, emtricitabine, and tenof…

• FDA approval · 2018-07-31
  FDA Approved: TENOFOVIR DISOPROXIL FUMARATE — Original Application (Chartwell RX, LLC.)

  FDA approved Tenofovir disoproxil fumarate tablets under an Original Application (ANDA) filed by Chartwell RX, LLC.

• FDA approval · 2018-07-30
  FDA Approved: VIREAD — Supplemental Application (Gilead Sciences, Inc.)

  FDA approved a supplemental application for VIREAD (tenofovir disoproxil fumarate) submitted by Gilead Sciences, resulting in an updated lab…

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• FDA approval · 2018-07-27
  FDA Approved: TYBOST — Supplemental Application (Gilead Sciences, Inc.)

  FDA has approved a supplemental application for TYBOST (cobicistat) submitted by Gilead Sciences, Inc.

• FDA approval · 2018-07-24
  FDA Approved: EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE — Supplemental Application (QUALLENT PHARMACEUTICALS HEALTH LLC)

  FDA approved a supplemental application for emtricitabine and tenofovir disoproxil fumarate from Quallent Pharmaceuticals Health LLC.

• FDA approval · 2018-07-24
  FDA Approved: EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for Emtricitabine and Tenofovir Disoproxil Fumarate by Teva Pharmaceuticals USA, Inc.

• FDA approval · 2018-07-24
  FDA Approved: EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application to allow Mylan Pharmaceuticals to market a generic fixed-dose combination of emtricitabine and tenof…

• FDA approval · 2018-07-18
  FDA Approved: SELZENTRY — Supplemental Application (ViiV Healthcare Company)

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

• FDA approval · 2018-07-17
  FDA Approved: SYMTUZA — Original Application (Janssen Products LP)

  FDA approved Symtuza, a fixed-dose single-tablet regimen containing darunavir, cobicistat, emtricitabine, and tenofovir alafenamide for HIV-…

• FDA approval · 2018-07-16
  FDA Approved: ETRAVIRINE — Supplemental Application (Patriot Pharmaceuticals)

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

• FDA approval · 2018-07-10
  FDA Approved: CIMDUO — Supplemental Application (Viatris Specialty LLC)

  The FDA approved a supplemental application for Cimduo (lamivudine and tenofovir disoproxil fumarate) submitted by Viatris Specialty LLC.

• FDA approval · 2018-07-02
  FDA Approved: EMTRICITABINE — Original Application (Cipla USA Inc.)

  FDA approved Cipla USA Inc.'s original application for generic emtricitabine, enabling its use in HIV-1 treatment regimens.

• FDA approval · 2018-06-25
  FDA Approved: ATAZANAVIR SULFATE — Original Application (Aurobindo Pharma Limited)

  FDA approved an original abbreviated new drug application for atazanavir sulfate from Aurobindo Pharma Limited. Atazanavir is used in the tr…

• FDA approval · 2018-06-22
  FDA Approved: APTIVUS — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

  FDA approved a supplemental application for APTIVUS (tipranavir) by Boehringer Ingelheim Pharmaceuticals, expanding its labeling.

• FDA approval · 2018-06-15
  FDA Approved: ISENTRESS — Supplemental Application (Merck Sharp & Dohme LLC)

  The FDA approved a supplemental application for Isentress (raltegravir) submitted by Merck Sharp & Dohme LLC, resulting in an approved regul…

• FDA approval · 2018-06-15
  FDA Approved: EFAVIRENZ — Original Application (Cipla USA Inc.)

  FDA approved the original application for efavirenz from Cipla USA Inc. as a generic version for HIV-1 infection. This marks another entry i…

• FDA approval · 2018-06-04
  FDA Approved: PREZCOBIX — Supplemental Application (Janssen Products, LP)

  The FDA approved a supplemental application for Prezcobix (darunavir ethanolate and cobicistat) from Janssen Products, LP.

• FDA approval · 2018-05-30
  FDA Approved: TROGARZO — Supplemental Application (Theratechnologies Inc.)

  FDA approved a supplemental application for TROGARZO (ibalizumab) submitted by Theratechnologies Inc., related to regulatory status for HIV-…

• FDA approval · 2018-05-15
  FDA Approved: RETACRIT — Original Application (Vifor (International) Inc.)

  The FDA approved Retacrit (epoetin alfa-epbx) under Original Application BLA125545, establishing it as a biosimilar to epoetin alfa. The app…

• FDA approval · 2018-05-09
  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 · 2018-04-27
  FDA Approved: COMBIVIR — Supplemental Application (ViiV Healthcare Company)

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

• FDA approval · 2018-04-27
  FDA Approved: EFAVIRENZ — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals' generic efavirenz under an original application, enabling its use in antiretroviral therapy for HIV inf…

• FDA approval · 2018-04-19
  FDA Approved: LAMIVUDINE — Original Application (Strides Pharma Science Limited)

  FDA approved Strides Pharma Science Limited's original ANDA for lamivudine, a generic antiviral used to treat HIV-1 infection and chronic he…