HIV Infection

• FDA approval · 2022-03-31
  FDA Approved: EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for Teva’s generic fixed-dose combination emtricitabine and tenofovir disoproxil fumarate. This …

• FDA approval · 2022-03-30
  FDA Approved: TRIUMEQ — Supplemental Application (ViiV Healthcare Company)

  The FDA approved a supplemental application for TRIUMEQ (abacavir sulfate, dolutegravir sodium, lamivudine) from ViiV Healthcare Company for…

• FDA approval · 2022-03-30
  FDA Approved: TRIUMEQ PD — Original Application (ViiV Healthcare Company)

  FDA approved TRIUMEQ PD, a fixed-dose combination of abacavir, dolutegravir, and lamivudine, under an Original Application for pediatric pat…

• FDA approval · 2022-03-29
  FDA Approved: EDURANT — Supplemental Application (Janssen Products, LP)

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

• FDA approval · 2022-03-29
  FDA Approved: VOCABRIA — Supplemental Application (ViiV Healthcare Company)

  The FDA approved a supplemental application for VOCABRIA (cabotegravir sodium) from ViiV Healthcare Company, enabling changes to the drug's …

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• FDA approval · 2022-03-29
  FDA Approved: CABENUVA — Supplemental Application (ViiV Healthcare Company)

  The FDA approved a supplemental application for CABENUVA (cabotegravir and rilpivirine), an injectable HIV treatment from ViiV Healthcare Co…

• FDA approval · 2022-03-23
  FDA Approved: VOCABRIA — Supplemental Application (ViiV Healthcare Company)

  FDA approved a supplemental application for VOCABRIA (cabotegravir sodium) from ViiV Healthcare Company.

• FDA approval · 2022-03-21
  FDA Approved: LOPINAVIR AND RITONAVIR — Original Application (Laurus Labs Limited)

  FDA approved an original application for a generic fixed-dose combination of lopinavir and ritonavir for HIV-1 infection, manufactured by La…

• FDA approval · 2022-02-07
  FDA Approved: VOCABRIA — Supplemental Application (ViiV Healthcare Company)

  FDA approved a supplemental application for VOCABRIA (cabotegravir sodium) filed by ViiV Healthcare Company under NDA 212887.

• FDA approval · 2022-02-07
  FDA Approved: CABENUVA — Supplemental Application (ViiV Healthcare Company)

  The FDA approved a supplemental application for CABENUVA (cabotegravir and rilpivirine) from ViiV Healthcare Company, resulting in changes t…

• FDA approval · 2022-02-07
  FDA Approved: MARAVIROC — Original Application (Camber Pharmaceuticals, Inc.)

  The FDA approved Camber Pharmaceuticals' original application for maraviroc, enabling a generic version of the HIV entry inhibitor.

• FDA approval · 2022-02-02
  FDA Approved: ATAZANAVIR — Original Application (Camber Pharmaceuticals, Inc.)

  The FDA approves Camber Pharmaceuticals' generic atazanavir (atazanavir) under an original drug application. The generic is indicated for th…

• FDA approval · 2022-01-31
  FDA Approved: EDURANT — Supplemental Application (Janssen Products, LP)

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

• FDA approval · 2022-01-31
  FDA Approved: CABENUVA — Supplemental Application (ViiV Healthcare Company)

  FDA approved a supplemental application for CABENUVA (cabotegravir and rilpivirine) to update its labeling for use as a complete regimen in …

• FDA approval · 2022-01-27
  FDA Approved: PIFELTRO — Supplemental Application (Merck Sharp & Dohme LLC)

  FDA approved a supplemental application for PIFELTRO (doravirine) by Merck Sharp & Dohme LLC, expanding its label for HIV-1 infection.

• FDA approval · 2022-01-27
  FDA Approved: DELSTRIGO — Supplemental Application (Merck Sharp & Dohme LLC)

  The FDA approved a supplemental application for Delstrigo, a fixed-dose combination HIV-1 therapy (doravirine/lamivudine/tenofovir disoproxi…

• FDA approval · 2022-01-24
  FDA Approved: EFAVIRENZ, EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approved a generic fixed-dose combination tablet containing efavirenz, emtricitabine, and tenofovir disoproxil fumarate for treatment of…

• FDA approval · 2022-01-24
  FDA Approved: RUKOBIA — Supplemental Application (ViiV Healthcare Company)

  FDA approved a supplemental application for Rukobia (fostemsavir tromamine) from ViiV Healthcare Company.

• FDA approval · 2022-01-20
  FDA Approved: DOVATO — Supplemental Application (ViiV Healthcare Company)

  FDA approved a supplemental NDA for Dovato (dolutegravir and lamivudine) from ViiV Healthcare Company. This action approves a modification/e…

• FDA approval · 2022-01-07
  FDA Approved: GENVOYA — Supplemental Application (Gilead Sciences, Inc.)

  The FDA approved a supplemental application for GENVOYA (elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide) to update its l…

• FDA approval · 2021-12-22
  FDA Approved: RITONAVIR FILM COATED — Supplemental Application (Cipla USA Inc.)

  FDA approved Cipla USA's supplemental application to add a film-coated 100 mg ritonavir tablet to the approved product, expanding the dosage…

• FDA approval · 2021-12-22
  FDA Approved: EFAVIRENZ, EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE — Original Application (Laurus Labs Limited)

  FDA approved Laurus Labs' generic fixed-dose combination tablet containing efavirenz, emtricitabine, and tenofovir disoproxil fumarate for t…

• FDA approval · 2021-12-20
  FDA Approved: VOCABRIA — Supplemental Application (ViiV Healthcare Company)

  The FDA has approved a supplemental application for VOCABRIA (cabotegravir sodium) from ViiV Healthcare Company. This action supplements the…

• FDA approval · 2021-10-07
  FDA Approved: BIKTARVY — Supplemental Application (Gilead Sciences, Inc.)

  The FDA approved a supplemental application for BIKTARVY (bictegravir, emtricitabine, and tenofovir alafenamide fumarate) submitted by Gilea…

• FDA approval · 2021-10-07
  FDA Approved: EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE — Original Application (Camber Pharmaceuticals, Inc.)

  The FDA approved Camber Pharmaceuticals' original-application generic combination emtricitabine and tenofovir disoproxil fumarate for treatm…