HIV Infection

• FDA approval · 2020-12-09
  FDA Approved: ZIDOVUDINE — Supplemental Application (Aurobindo Pharma Limited)

  The FDA granted a supplemental approval for Zidovudine (generic) manufactured by Aurobindo Pharma Limited under an ANDA.

• FDA approval · 2020-11-24
  FDA Approved: ZIAGEN — Supplemental Application (ViiV Healthcare Company)

  FDA approved a supplemental application for Ziagen (abacavir sulfate) by ViiV Healthcare Company.

• FDA approval · 2020-11-23
  FDA Approved: EFAVIRENZ, EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE — Supplemental Application (Cipla USA Inc.)

  FDA approved a supplemental application for a fixed-dose combination antiretroviral drug containing efavirenz, emtricitabine, and tenofovir …

• FDA approval · 2020-11-16
  FDA Approved: MYTESI — Supplemental Application (Napo Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Mytesi (crofelemer) submitted by Napo Pharmaceuticals, Inc.

• FDA approval · 2020-10-30
  FDA Approved: SELZENTRY — Supplemental Application (ViiV Healthcare Company)

  The FDA approved a supplemental application for SELZENTRY (maraviroc) from ViiV Healthcare Company, resulting in an update to the drug's lab…

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• FDA approval · 2020-10-21
  FDA Approved: KALETRA — Supplemental Application (AbbVie Inc.)

  FDA approved a supplemental application for KALETRA (lopinavir/ritonavir) submitted by AbbVie Inc.

• FDA approval · 2020-10-21
  FDA Approved: NORVIR — Supplemental Application (AbbVie Inc.)

  FDA approved a supplemental application for NORVIR (ritonavir) from AbbVie Inc.

• FDA approval · 2020-10-21
  FDA Approved: KALETRA — Supplemental Application (AbbVie Inc.)

  FDA approved a supplemental application for KALETRA (lopinavir/ritonavir) submitted by AbbVie, updating the status of this antiretroviral th…

• FDA approval · 2020-10-21
  FDA Approved: NORVIR — Supplemental Application (AbbVie Inc.)

  FDA approved a supplemental application for Norvir (ritonavir) from AbbVie.

• EMA approval · 2020-10-16
  First long-acting injectable antiretroviral therapy for HIV recommended for approval

  The EMA recommends approval of the first long-acting injectable antiretroviral therapy for HIV, representing a new treatment option with les…

• FDA approval · 2020-09-24
  FDA Approved: REYATAZ — Supplemental Application (E.R. Squibb & Sons, L.L.C.)

  FDA approved a supplemental application for REYATAZ (atazanavir), indicating a modification to the approved labeling. The submission was fil…

• FDA approval · 2020-09-24
  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 · 2020-08-21
  FDA Approved: STRIBILD — Supplemental Application (Gilead Sciences, Inc.)

  The FDA approved a supplemental application for STRIBILD, a fixed-dose combination antiretroviral therapy.

• FDA approval · 2020-08-06
  FDA Approved: DOVATO — Supplemental Application (ViiV Healthcare Company)

  FDA approved a supplemental application for DOVATO (dolutegravir sodium and lamivudine) submitted by ViiV Healthcare Company.

• FDA approval · 2020-07-31
  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. The action pertains to th…

• FDA approval · 2020-07-21
  FDA Approved: NEVIRAPINE — Supplemental Application (Micro Labs Limited)

  FDA approved a supplemental application for NEVIRAPINE from Micro Labs Limited (ANDA 203080), authorizing a generic NEVIRAPINE product.

• FDA approval · 2020-07-14
  FDA Approved: ISENTRESS — Supplemental Application (Merck Sharp & Dohme LLC)

  The FDA approved a supplemental application for Isentress (raltegravir) submitted by Merck Sharp & Dohme LLC.

• FDA approval · 2020-07-14
  FDA Approved: ISENTRESS — Supplemental Application (Merck Sharp & Dohme LLC)

  FDA approved a supplemental application for ISENTRESS (raltegravir) submitted by Merck Sharp & Dohme LLC.

• FDA approval · 2020-07-14
  FDA Approved: JULUCA — Supplemental Application (ViiV Healthcare Company)

  FDA approves a supplemental application for JULUCA (dolutegravir sodium and rilpivirine hydrochloride) submitted by ViiV Healthcare Company.

• FDA approval · 2020-07-14
  FDA Approved: ISENTRESS — Supplemental Application (Merck Sharp & Dohme LLC)

  The FDA approved a supplemental application for Isentress (raltegravir) submitted by Merck Sharp & Dohme LLC. The action represents an updat…

• FDA approval · 2020-07-02
  FDA Approved: RUKOBIA — Original Application (ViiV Healthcare Company)

  FDA approved RUKOBIA (fostemsavir tromamine) via an original application to treat HIV-1 infection in adults with multidrug resistance, repre…

• FDA approval · 2020-06-24
  FDA Approved: NEVIRAPINE — Supplemental Application (Camber Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for nevirapine from Camber Pharmaceuticals, approving changes to the generic product under an ab…

• FDA approval · 2020-06-18
  FDA Approved: RETROVIR — Supplemental Application (ViiV Healthcare Company)

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

• FDA approval · 2020-06-18
  FDA Approved: RETROVIR — Supplemental Application (ViiV Healthcare Company)

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

• FDA approval · 2020-06-18
  FDA Approved: APTIVUS — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Aptivus (tipranavir) submitted by Boehringer Ingelheim Pharmaceuticals, Inc.