HIV Infection

• FDA approval · 2023-06-07
  FDA Approved: NEVIRAPINE — Supplemental Application (Macleods Pharmaceuticals Limited)

  FDA approved the supplemental application for NEVIRAPINE filed by Macleods Pharmaceuticals Limited.

• FDA approval · 2023-05-12
  FDA Approved: EVOTAZ — Supplemental Application (E.R. Squibb & Sons, L.L.C.)

  The FDA approved a supplemental application for EVOTAZ (atazanavir and cobicistat) from E.R. Squibb & Sons, L.L.C.

• FDA approval · 2023-05-05
  FDA Approved: LAMIVUDINE — Supplemental Application (Apotex Corp.)

  FDA approved a supplemental application for lamivudine by Apotex Corp., enabling the generic lamivudine product to be marketed.

• FDA approval · 2023-05-01
  FDA Approved: BIKTARVY — Supplemental Application (Gilead Sciences, Inc.)

  FDA approved a supplemental application for BIKTARVY, submitted by Gilead Sciences, Inc.

• EMA approval · 2023-04-25
  EMA Authorised: Stocrin (efavirenz) — Merck Sharp & Dohme B.V.

  EFAVIRENZ (Stocrin) has been authorised by the EMA for HIV infections.

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• FDA approval · 2023-04-25
  FDA Approved: ABACAVIR SULFATE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for Abacavir Sulfate submitted by Mylan Pharmaceuticals Inc.

• FDA approval · 2023-04-25
  FDA Approved: TENOFOVIR DISOPROXIL FUMARATE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Tenofovir disoproxil fumarate by Aurobindo Pharma Limited. This approval relates to a generic pr…

• FDA approval · 2023-04-19
  FDA Approved: LAMIVUDINE AND ZIDOVUDINE — Supplemental Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals' supplemental application for a generic lamivudine and zidovudine tablet product, a fixed-dose combinati…

• FDA approval · 2023-04-18
  FDA Approved: ABACAVIR AND LAMIVUDINE — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for Abacavir/lamivudine from Aurobindo Pharma Limited, enabling the marketing of this generic fi…

• FDA approval · 2023-04-14
  FDA Approved: REYATAZ — Supplemental Application (E.R. Squibb & Sons, L.L.C.)

  FDA approved a supplemental application for Reyataz (atazanavir) submitted by E.R. Squibb & Sons, L.L.C.

• FDA approval · 2023-04-06
  FDA Approved: EFAVIRENZ — Supplemental Application (Camber Pharmaceuticals, Inc.)

  FDA approves Camber Pharmaceuticals' supplemental application for efavirenz (generic) as an antiretroviral for HIV-1 infection.

• FDA approval · 2023-04-05
  FDA Approved: LAMIVUDINE AND ZIDOVUDINE — Supplemental Application (Exelan Pharmaceuticals Inc.)

  FDA approved a supplemental application for Lamivudine and Zidovudine from Exelan Pharmaceuticals, confirming continued availability of this…

• FDA approval · 2023-03-31
  FDA Approved: PREZISTA — Supplemental Application (Janssen Products LP)

  The FDA approves a supplemental application for Prezista (darunavir) from Janssen Products LP.

• FDA approval · 2023-03-31
  FDA Approved: PREZISTA — Supplemental Application (Janssen Products LP)

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

• FDA approval · 2023-03-31
  FDA Approved: NEVIRAPINE — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for Nevirapine by Aurobindo Pharma Limited. This action records a supplementary approval for a g…

• FDA approval · 2023-03-31
  FDA Approved: PREZCOBIX — Supplemental Application (Janssen Products, LP)

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

• FDA approval · 2023-03-31
  FDA Approved: SYMTUZA — Supplemental Application (Janssen Products LP)

  The FDA approved a supplemental application for SYMTUZA (darunavir, cobicistat, emtricitabine, and tenofovir alafenamide), a fixed-dose HIV-…

• FDA approval · 2023-03-30
  FDA Approved: ABACAVIR — Supplemental Application (Aurobindo Pharma Limited)

  FDA approves a supplemental application for abacavir from Aurobindo Pharma Limited.

• FDA approval · 2023-03-15
  FDA Approved: EMTRICITABINE — Original Application (Aurobindo Pharma Limited)

  FDA approved the original application for emtricitabine from Aurobindo Pharma Limited (ANDA).

• FDA approval · 2023-03-09
  FDA Approved: EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE — Original Application (Aurobindo Pharma Limited)

  FDA approved Aurobindo Pharma Limited's generic fixed-dose combination emtricitabine and tenofovir disoproxil fumarate for HIV-1 infection v…

• EMA approval · 2023-03-03
  EMA Authorised: Efavirenz Teva (efavirenz) — Teva B.V.

  EFAVIRZEN Teva has been authorised in the EU for HIV infection treatment.

• FDA approval · 2023-02-27
  FDA Approved: VOCABRIA — Supplemental Application (ViiV Healthcare Company)

  FDA approved a supplemental application for VOCABRIA (cabotegravir sodium) filed by ViiV Healthcare Company. The action updates the labeling…

• FDA approval · 2023-02-27
  FDA Approved: CABENUVA — Supplemental Application (ViiV Healthcare Company)

  The FDA approved a supplemental application for CABENUVA, the long-acting HIV-1 treatment regimen of cabotegravir and rilpivirine, filed by …

• FDA approval · 2023-02-27
  FDA Approved: APRETUDE — Supplemental Application (ViiV Healthcare Company)

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

• EMA approval · 2023-02-14
  EMA Authorised: Tybost (cobicistat) — Gilead Sciences Ireland UC

  Authorisation of Tybost (cobicistat) by EMA for use in HIV infections.