HIV Infection

• FDA label_change · 2013-11-27
  FDA Approved: TRUVADA — Supplemental Application (Gilead Sciences, Inc)

  FDA approved a supplemental application for TRUVADA (emtricitabine and tenofovir disoproxil fumarate) submitted by Gilead, indicating a chan…

• FDA label_change · 2013-06-14
  FDA Approved: PREZISTA — Supplemental Application (Janssen Products LP)

  FDA approved a supplemental application for Prezista (darunavir) filed by Janssen Products LP, resulting in updated labeling.

• FDA label_change · 2012-05-31
  FDA Approved: RETROVIR — Supplemental Application (ViiV Healthcare Company)

  FDA approved a supplemental application for RETROVIR (zidovudine) from ViiV Healthcare Company, potentially leading to labeling changes.

• FDA label_change · 2011-02-24
  FDA Approved: KALETRA — Supplemental Application (AbbVie Inc.)

  FDA approved a supplemental application for KALETRA (lopinavir/ritonavir), updating its labeling.

• FDA label_change · 2008-04-04
  FDA Approved: EMTRIVA — Supplemental Application (Gilead Sciences, Inc.)

  The FDA approved a supplemental application for Emtriva (emtricitabine) to update its labeling, reflecting changes approved for the product.

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA label_change · 2008-02-20
  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., resulting in changes to the dr…

• FDA label_change · 2007-10-04
  FDA Approved: APTIVUS — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Aptivus (tipranavir) filed by Boehringer Ingelheim, resulting in a modification to the product l…

• FDA label_change · 2006-10-25
  FDA Approved: COMBIVIR — Supplemental Application (ViiV Healthcare Company)

  The FDA approved a supplemental application for COMBIVIR (lamivudine and zidovudine) from ViiV Healthcare Company.

• FDA label_change · 2006-08-09
  FDA Approved: REYATAZ — Supplemental Application (E.R. Squibb & Sons, L.L.C.)

  FDA approved a supplemental application for REYATAZ (atazanavir) filed by E.R. Squibb & Sons, L.L.C. The approval updates the product labeli…