HIV Infection

• FDA approval · 2024-12-18
  FDA Approved: RETROVIR — Supplemental Application (ViiV Healthcare Company)

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

• FDA approval · 2024-12-12
  FDA Approved: NEVIRAPINE — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for Nevirapine submitted by Aurobindo Pharma Limited.

• FDA approval · 2024-12-05
  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., updating the labeling as part of an ap…

• FDA approval · 2024-12-04
  FDA Approved: EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE — Supplemental Application (Zydus Pharmaceuticals USA Inc.)

  FDA approves a supplemental application for Emtricitabine and Tenofovir Disoproxil Fumarate by Zydus Pharmaceuticals USA Inc., confirming re…

• FDA approval · 2024-11-25
  FDA Approved: SUNLENCA — Supplemental Application (Gilead Sciences, Inc.)

  The FDA approved a supplemental application for Sunlenca (lenacapavir sodium) from Gilead Sciences. This action approves a supplemental NDA …

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• FDA approval · 2024-11-25
  FDA Approved: SUNLENCA — Supplemental Application (Gilead Sciences, Inc.)

  The FDA approved a supplemental application for Sunlenca (lenacapavir sodium) submitted by Gilead Sciences, Inc. The action pertains to the …

• FDA approval · 2024-11-22
  FDA Approved: EFAVIRENZ — Supplemental Application (Camber Pharmaceuticals, Inc.)

  The FDA approved Camber Pharmaceuticals' supplemental application for efavirenz, a generic antiretroviral for HIV-1 infection.

• FDA approval · 2024-11-21
  FDA Approved: EMTRICITABINE — Supplemental Application (Cipla USA Inc.)

  FDA approved a supplemental application for Emtricitabine submitted by Cipla USA Inc., updating the approved labeling for the drug.

• FDA approval · 2024-11-21
  FDA Approved: EFAVIRENZ, EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved Teva's supplemental application for a generic fixed-dose combination of efavirenz, emtricitabine and tenofovir disoproxil f…

• FDA approval · 2024-11-14
  FDA Approved: EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE — Supplemental Application (Strides Pharma Science Limited)

  FDA approved a supplemental application for the generic combination emtricitabine and tenofovir disoproxil fumarate from Strides Pharma Scie…

• FDA approval · 2024-11-13
  FDA Approved: SUNLENCA — Supplemental Application (Gilead Sciences, Inc.)

  This document reports an FDA supplemental application submission for Sunlenca (lenacapavir sodium) by Gilead Sciences, Inc., with the submis…

• FDA approval · 2024-11-11
  FDA Approved: RETROVIR — Supplemental Application (ViiV Healthcare Company)

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

• FDA approval · 2024-11-07
  FDA Approved: DELSTRIGO — Supplemental Application (Merck Sharp & Dohme LLC)

  FDA approved a supplemental application for Delstrigo (doravirine/lamivudine/tenofovir disoproxil fumarate) submitted by Merck, resulting in…

• FDA approval · 2024-11-07
  FDA Approved: PIFELTRO — Supplemental Application (Merck Sharp & Dohme LLC)

  FDA approved a supplemental application for PIFELTRO (doravirine) from Merck Sharp & Dohme LLC, updating the drug's labeling.

• FDA approval · 2024-10-23
  FDA Approved: NEVIRAPINE — Supplemental Application (Camber Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Nevirapine from Camber Pharmaceuticals (ANDA078584), approving changes to the generic produc…

• FDA approval · 2024-10-18
  FDA Approved: ATAZANAVIR SULFATE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for Atazanavir Sulfate (Teva Pharmaceuticals USA, Inc.). This reflects a regulatory update to the dr…

• EMA approval · 2024-10-16
  EMA Authorised: Reyataz (atazanavir (as sulfate)) — Bristol-Myers Squibb Pharma EEIG

  The EMA authorised Reyataz (atazanavir sulfate) for HIV infections; the marketing authorization holder is Bristol-Myers Squibb Pharma EEIG.

• FDA approval · 2024-10-08
  FDA Approved: BIKTARVY — Supplemental Application (Gilead Sciences, Inc.)

  The FDA approved a supplemental application for BIKTARVY, the fixed-dose combination HIV-1 therapy from Gilead Sciences.

• FDA approval · 2024-09-20
  FDA Approved: APRETUDE — Supplemental Application (ViiV Healthcare Company)

  FDA approves a supplemental application for APRETUDE (cabotegravir) submitted by ViiV Healthcare Company.

• FDA approval · 2024-09-20
  FDA Approved: VOCABRIA — Supplemental Application (ViiV Healthcare Company)

  FDA approved a supplemental application for Vocabria (cabotegravir sodium) submitted by ViiV Healthcare Company.

• FDA approval · 2024-09-20
  FDA Approved: CABENUVA — Supplemental Application (ViiV Healthcare Company)

  FDA approved a supplemental application for CABENUVA, the monthly injectable regimen of cabotegravir and rilpivirine, submitted by ViiV Heal…

• FDA approval · 2024-09-19
  FDA Approved: LAMIVUDINE AND ZIDOVUDINE — Supplemental Application (Camber Pharmaceuticals, Inc.)

  The FDA approved Camber Pharmaceuticals' supplemental application for a generic Lamivudine and Zidovudine fixed-dose combination, expanding …

• FDA approval · 2024-09-16
  FDA Approved: EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for emtricitabine and tenofovir disoproxil fumarate by Mylan Pharmaceuticals Inc., authorizing a gen…

• FDA approval · 2024-08-22
  FDA Approved: NEVIRAPINE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for nevirapine (NEVIRAPINE) from Mylan Pharmaceuticals Inc., granting a supplemental approval for th…

• EMA approval · 2024-08-13
  EMA Authorised: Intelence (Etravirine) — Janssen-Cilag International NV

  The European Medicines Agency authorised Intelence (etravirine) for HIV infections, with Janssen-Cilag International NV as the marketing aut…