HIV Infection

• FDA approval · 2015-03-23
  FDA Approved: EPIVIR — Supplemental Application (ViiV Healthcare Company)

  The FDA approved a supplemental application for EPIVIR (lamivudine) submitted by ViiV Healthcare Company, indicating changes to its labeling…

• FDA approval · 2015-03-16
  FDA Approved: NORVIR — Supplemental Application (AbbVie Inc.)

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

• FDA approval · 2015-02-26
  FDA Approved: REYATAZ — Supplemental Application (E.R. Squibb & Sons, L.L.C.)

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

• FDA approval · 2015-02-20
  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 updates the product…

• FDA approval · 2015-02-20
  FDA Approved: ISENTRESS — Supplemental Application (Merck Sharp & Dohme LLC)

  The FDA approved a supplemental application for Isentress (raltegravir) from Merck Sharp & Dohme LLC. The approval updates labeling and/or i…

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2015-02-20
  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 updates the product…

• FDA approval · 2015-02-19
  FDA Approved: EPIVIR — Supplemental Application (ViiV Healthcare Company)

  The FDA approved a supplemental application for EPIVIR (lamivudine) submitted by ViiV Healthcare Company.

• FDA approval · 2015-02-19
  FDA Approved: ZIAGEN — Supplemental Application (ViiV Healthcare Company)

  The FDA approved a supplemental application for ZIAGEN (abacavir sulfate) submitted by ViiV Healthcare Company.

• FDA approval · 2015-02-19
  FDA Approved: EPIVIR — Supplemental Application (ViiV Healthcare Company)

  The FDA approved a supplemental application for EPIVIR (lamivudine) submitted by ViiV Healthcare Company.

• FDA approval · 2015-02-18
  FDA Approved: ISENTRESS — Supplemental Application (Merck Sharp & Dohme LLC)

  This FDA entry announces a supplemental application for ISENTRESS (raltegravir) filed by Merck Sharp & Dohme LLC.

• FDA approval · 2015-02-18
  FDA Approved: ISENTRESS — Supplemental Application (Merck Sharp & Dohme LLC)

  FDA approved a supplemental application for Isentress (raltegravir) from Merck, updating its labeling for HIV-1 infection.

• FDA approval · 2015-02-18
  FDA Approved: ISENTRESS — Supplemental Application (Merck Sharp & Dohme LLC)

  FDA approved a supplemental application for Isentress (raltegravir) submitted by Merck Sharp & Dohme LLC. The snippet provided does not spec…

• FDA approval · 2015-02-03
  FDA Approved: PREZISTA — Supplemental Application (Janssen Products LP)

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

• FDA approval · 2015-01-29
  FDA Approved: PREZCOBIX — Original Application (Janssen Products, LP)

  FDA approved PrezcoBix (darunavir ethanolate and cobicistat) on its original application for the treatment of HIV-1 infection. This represen…

• FDA approval · 2015-01-29
  FDA Approved: EVOTAZ — Original Application (E.R. Squibb & Sons, L.L.C.)

  FDA approved EVOTAZ, a fixed-dose combination of atazanavir and cobicistat for the treatment of HIV-1 infection, with cobicistat acting as a…

• FDA approval · 2015-01-28
  FDA Approved: KALETRA — Supplemental Application (AbbVie Inc.)

  The FDA approved a supplemental application for KALETRA (lopinavir/ritonavir) from AbbVie. This action signifies a supplemental NDA approval…

• FDA approval · 2015-01-28
  FDA Approved: KALETRA — Supplemental Application (AbbVie Inc.)

  FDA approved a supplemental application for KALETRA (lopinavir and ritonavir) from AbbVie, resulting in an updated regulatory action for the…

• FDA approval · 2015-01-20
  FDA Approved: NEVIRAPINE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Nevirapine from Aurobindo Pharma Limited.

• FDA approval · 2015-01-15
  FDA Approved: RITONAVIR FILM COATED — Original Application (Cipla USA Inc.)

  The FDA approved Ritonavir Film Coated 100 mg as an Original Application (ANDA) for Cipla USA Inc., a generic ritonavir product. This marks …

• FDA approval · 2014-12-23
  FDA Approved: RETROVIR — Supplemental Application (ViiV Healthcare Company)

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

• FDA approval · 2014-12-23
  FDA Approved: RETROVIR — Supplemental Application (ViiV Healthcare Company)

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

• FDA approval · 2014-12-23
  FDA Approved: RETROVIR — Supplemental Application (ViiV Healthcare Company)

  The FDA approved a supplemental application for RETROVIR (Zidovudine) submitted by ViiV Healthcare Company under NDA019951.

• FDA approval · 2014-12-19
  FDA Approved: TIVICAY — Supplemental Application (ViiV Healthcare Company)

  The FDA approved a supplemental application for Tivicay (dolutegravir) from ViiV Healthcare Company. The action relates to a supplemental su…

• FDA approval · 2014-12-18
  FDA Approved: LAMIVUDINE — Original Application (Lupin Pharmaceuticals, Inc.)

  FDA approves Lupin Pharmaceuticals' original application for lamivudine as a generic product.

• FDA approval · 2014-12-17
  FDA Approved: STRIBILD — Supplemental Application (Gilead Sciences, Inc.)

  FDA approved a supplemental application for STRIBILD, the fixed-dose HIV-1 treatment, potentially updating its label and/or indications.