HIV Infection

• FDA approval · 2007-09-25
  FDA Approved: KALETRA — Supplemental Application (AbbVie Inc.)

  The FDA approved a supplemental application for KALETRA (lopinavir/ritonavir) from AbbVie. This action updates the product's labeling or ind…

• FDA approval · 2007-09-25
  FDA Approved: KALETRA — Supplemental Application (AbbVie Inc.)

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

• FDA approval · 2007-08-06
  FDA Approved: SELZENTRY — Original Application (ViiV Healthcare Company)

  FDA approval of Selzentry (maraviroc) by ViiV Healthcare as the original NDA, for treatment of CCR5-tropic HIV-1 infection in adults and cer…

• FDA approval · 2007-07-31
  FDA Approved: VIRACEPT — Supplemental Application (AGOURON)

  The FDA approved a supplemental application for Viracept (nelfinavir mesylate) from Agouron Pharmaceuticals.

• FDA approval · 2007-07-31
  FDA Approved: VIRACEPT — Supplemental Application (AGOURON)

  The FDA approved a supplemental application for Viracept (nelfinavir mesylate) submitted by Agouron.

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• FDA approval · 2007-06-29
  FDA Approved: KALETRA — Supplemental Application (AbbVie Inc.)

  The FDA has approved a supplemental application for KALETRA (lopinavir/ritonavir) from AbbVie Inc. The notice indicates a supplemental appro…

• FDA approval · 2007-06-29
  FDA Approved: KALETRA — Supplemental Application (AbbVie Inc.)

  The FDA approved a supplemental application for KALETRA (lopinavir/ritonavir) submitted by AbbVie Inc. This action indicates an update to th…

• FDA approval · 2007-06-19
  FDA Approved: ZIDOVUDINE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Zidovudine from Aurobindo Pharma Limited, updating an existing Zidovudine product.

• FDA approval · 2007-05-21
  FDA Approved: VIREAD — Supplemental Application (Gilead Sciences, Inc.)

  FDA approved a supplemental application for VIREAD (tenofovir disoproxil fumarate) to update its labeling.

• FDA approval · 2007-05-14
  FDA Approved: APTIVUS — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Aptivus (tipranavir) filed by Boehringer Ingelheim Pharmaceuticals. The approval indicates a…

• FDA approval · 2007-05-07
  FDA Approved: ZIAGEN — Supplemental Application (ViiV Healthcare Company)

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

• FDA approval · 2007-04-25
  FDA Approved: PREZISTA — Supplemental Application (Janssen Products LP)

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

• FDA approval · 2007-04-20
  FDA Approved: KALETRA — Supplemental Application (AbbVie Inc.)

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

• FDA approval · 2007-04-20
  FDA Approved: KALETRA — Supplemental Application (AbbVie Inc.)

  FDA approved a supplemental application for KALETRA (lopinavir/ritonavir) submitted by AbbVie Inc. The approval authorizes changes to the pr…

• FDA approval · 2007-03-22
  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 · 2007-03-02
  FDA Approved: KALETRA — Supplemental Application (AbbVie Inc.)

  The FDA approved a supplemental application for Kaletra (lopinavir/ritonavir) from AbbVie, indicating an approval of a modification to the e…

• FDA approval · 2007-03-02
  FDA Approved: KALETRA — Supplemental Application (AbbVie Inc.)

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

• FDA approval · 2006-12-22
  FDA Approved: VIRACEPT — Supplemental Application (AGOURON)

  FDA approved a supplemental application for Viracept (nelfinavir mesylate) submitted by Agouron.

• FDA approval · 2006-12-22
  FDA Approved: EMTRIVA — Supplemental Application (Gilead Sciences, Inc.)

  The FDA approved a supplemental application for EMTRIVA (emtricitabine) from Gilead Sciences.

• FDA approval · 2006-12-22
  FDA Approved: VIRACEPT — Supplemental Application (AGOURON)

  The FDA approved a supplemental application for VIRACEPT (nelfinavir) from Agouron. This action approves an additional aspect of the drug's …

• FDA approval · 2006-12-21
  FDA Approved: KALETRA — Supplemental Application (AbbVie Inc.)

  FDA approved a supplemental application for Kaletra (lopinavir/ritonavir) submitted by AbbVie. The approval relates to its use for HIV infec…

• FDA approval · 2006-12-21
  FDA Approved: KALETRA — Supplemental Application (AbbVie Inc.)

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

• FDA approval · 2006-11-20
  FDA Approved: PREZISTA — Supplemental Application (Janssen Products LP)

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

• FDA approval · 2006-11-15
  FDA Approved: RETROVIR — Supplemental Application (ViiV Healthcare Company)

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

• FDA approval · 2006-11-15
  FDA Approved: RETROVIR — Supplemental Application (ViiV Healthcare Company)

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