HIV Infection

• FDA approval · 2018-11-15
  FDA Approved: NORVIR — Supplemental Application (AbbVie Inc.)

  The FDA approved a supplemental application for Norvir (ritonavir) submitted by AbbVie.

• FDA approval · 2018-11-15
  FDA Approved: ABACAVIR AND LAMIVUDINE — Original Application (Aurobindo Pharma Limited)

  FDA approved a fixed-dose combination generic tablet of abacavir and lamivudine via an original ANDA from Aurobindo Pharma Limited for HIV-1…

• FDA approval · 2018-11-09
  FDA Approved: EFAVIRENZ, EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE — Original Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Teva's generic fixed-dose combination efavirenz/emtricitabine/tenofovir disoproxil fumarate for HIV-1 infection.

• FDA approval · 2018-11-06
  FDA Approved: ETRAVIRINE — Supplemental Application (Patriot Pharmaceuticals)

  The FDA approved a supplemental application for etravirine submitted by Patriot Pharmaceuticals. The action represents approval of a supplem…

• FDA approval · 2018-11-02
  FDA Approved: STRIBILD — Supplemental Application (Gilead Sciences, Inc.)

  The FDA approved a supplemental application for STRIBILD from Gilead, updating the drug's labeling to reflect the supplemental submission.

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• FDA approval · 2018-11-02
  FDA Approved: GENVOYA — Supplemental Application (Gilead Sciences, Inc.)

  FDA approved a supplemental application for GENVOYA (elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide) from Gilead Science…

• FDA approval · 2018-10-31
  FDA Approved: COMPLERA — Supplemental Application (Gilead Sciences, Inc.)

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

• FDA approval · 2018-10-31
  FDA Approved: ODEFSEY — Supplemental Application (Gilead Sciences, Inc.)

  FDA approved a supplemental application for ODEFSEY (emtricitabine, rilpivirine hydrochloride, and tenofovir alafenamide) from Gilead Scienc…

• FDA approval · 2018-10-30
  FDA Approved: TYBOST — Supplemental Application (Gilead Sciences, Inc.)

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

• FDA approval · 2018-09-21
  FDA Approved: EFAVIRENZ — Original Application (Aurobindo Pharma Limited)

  FDA approves Aurobindo Pharma Limited's generic efavirenz (original ANDA) for the treatment of HIV-1 infection.

• FDA approval · 2018-09-17
  FDA Approved: RITONAVIR — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals' original application for Ritonavir, a generic protease inhibitor used in HIV therapy as a pharmacokinet…

• FDA approval · 2018-09-17
  FDA Approved: RITONAVIR — Original Application (Aurobindo Pharma Limited)

  FDA approved Aurobindo Pharma Limited's Ritonavir original application (ANDA 206614), granting approval for a generic Ritonavir product.

• FDA approval · 2018-09-17
  FDA Approved: RITONAVIR — Original Application (Amneal Pharmaceuticals LLC)

  FDA approved Amneal Pharmaceuticals LLC's original ANDA for ritonavir, confirming a generic ritonavir product is eligible for marketing. Rit…

• FDA approval · 2018-09-10
  FDA Approved: RETROVIR — Supplemental Application (ViiV Healthcare Company)

  FDA approved a supplemental application for Retrovir (Zidovudine) submitted by ViiV Healthcare Company.

• FDA approval · 2018-09-10
  FDA Approved: RETROVIR — Supplemental Application (ViiV Healthcare Company)

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

• FDA approval · 2018-09-10
  FDA Approved: RETROVIR — Supplemental Application (ViiV Healthcare Company)

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

• FDA approval · 2018-09-07
  FDA Approved: PREZISTA — Supplemental Application (Janssen Products LP)

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

• FDA approval · 2018-09-07
  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 · 2018-09-06
  FDA Approved: JULUCA — Supplemental Application (ViiV Healthcare Company)

  The FDA approved a supplemental application for JULUCA (dolutegravir and rilpivirine) from ViiV Healthcare, updating its label for HIV-1 tre…

• FDA approval · 2018-09-06
  FDA Approved: TRIUMEQ — Supplemental Application (ViiV Healthcare Company)

  FDA approves a supplemental application for TRIUMEQ (abacavir sulfate, dolutegravir sodium, lamivudine) from ViiV Healthcare Company.

• FDA approval · 2018-09-06
  FDA Approved: TIVICAY — Supplemental Application (ViiV Healthcare Company)

  FDA approved a supplemental application for TIVICAY (dolutegravir) from ViiV Healthcare Company.

• FDA approval · 2018-09-04
  FDA Approved: EFAVIRENZ, EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE — Original Application (Aurobindo Pharma Limited)

  FDA approved an original ANDA for a generic fixed-dose combination tablet containing efavirenz, emtricitabine, and tenofovir disoproxil fuma…

• FDA approval · 2018-08-30
  FDA Approved: PIFELTRO — Original Application (Merck Sharp & Dohme LLC)

  FDA approved PIFELTRO (doravirine) as an original approval for HIV-1 infection in adults and certain pediatric patients as part of combinati…

• FDA approval · 2018-08-30
  FDA Approved: DELSTRIGO — Original Application (Merck Sharp & Dohme LLC)

  The FDA approved Delstrigo, a fixed-dose combination tablet containing doravirine, lamivudine, and tenofovir disoproxil fumarate, as a compl…

• FDA approval · 2018-08-29
  FDA Approved: LAMIVUDINE AND ZIDOVUDINE — Original Application (Macleods Pharmaceuticals Limited)

  The FDA approved a generic fixed-dose combination tablet of lamivudine and zidovudine under an Original Application (ANDA) by Macleods Pharm…