HIV Infection

• FDA approval · 2009-11-05
  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 an approved updat…

• FDA approval · 2009-11-04
  FDA Approved: ISENTRESS — Supplemental Application (Merck Sharp & Dohme LLC)

  FDA approved a supplemental application for Isentress (raltegravir) submitted by Merck Sharp & Dohme LLC. Isentress is an antiretroviral the…

• FDA approval · 2009-09-15
  FDA Approved: ETRAVIRINE — Supplemental Application (Patriot Pharmaceuticals)

  FDA approved a supplemental application for etravirine submitted by Patriot Pharmaceuticals (NDA 022187).

• FDA approval · 2009-07-08
  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 · 2009-06-19
  FDA Approved: APTIVUS — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

  FDA approved a supplemental application for APTIVUS (tipranavir) from Boehringer Ingelheim Pharmaceuticals, Inc.

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2009-06-15
  FDA Approved: PREZISTA — Supplemental Application (Janssen Products LP)

  The FDA approved a supplemental application for PREZISTA (darunavir) submitted by Janssen Products LP. This action approves a regulatory sup…

• FDA approval · 2009-05-13
  FDA Approved: ZIDOVUDINE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Zidovudine (AZT) from Aurobindo Pharma Limited.

• FDA approval · 2009-05-13
  FDA Approved: ZIDOVUDINE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Zidovudine from Aurobindo Pharma Limited, authorizing changes under the approved generic product…

• FDA approval · 2009-05-08
  FDA Approved: ZIDOVUDINE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Zidovudine from Aurobindo Pharma Limited, authorizing the marketing of a generic Zidovudine prod…

• FDA approval · 2009-04-20
  FDA Approved: KALETRA — Supplemental Application (AbbVie Inc.)

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

• FDA approval · 2009-04-20
  FDA Approved: KALETRA — Supplemental Application (AbbVie Inc.)

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

• FDA approval · 2009-04-06
  FDA Approved: KALETRA — Supplemental Application (AbbVie Inc.)

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

• FDA approval · 2009-04-06
  FDA Approved: KALETRA — Supplemental Application (AbbVie Inc.)

  The FDA approved a supplemental application for Kaletra (lopinavir/ritonavir) submitted by AbbVie Inc. The document indicates the submission…

• FDA approval · 2009-03-05
  FDA Approved: ZIDOVUDINE — Supplemental Application (Camber Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Zidovudine from Camber Pharmaceuticals, Inc., enabling a generic version to be marketed. Thi…

• FDA approval · 2009-02-02
  FDA Approved: COMBIVIR — Supplemental Application (ViiV Healthcare Company)

  FDA approves a supplemental application for COMBIVIR (lamivudine and zidovudine) submitted by ViiV Healthcare Company.

• FDA approval · 2009-01-29
  FDA Approved: ISENTRESS — Supplemental Application (Merck Sharp & Dohme LLC)

  FDA approved a supplemental application for Isentress (raltegravir) from Merck, updating the product labeling.

• FDA approval · 2009-01-13
  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 · 2008-12-19
  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 · 2008-12-18
  FDA Approved: PREZISTA — Supplemental Application (Janssen Products LP)

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

• FDA approval · 2008-11-25
  FDA Approved: SELZENTRY — Supplemental Application (ViiV Healthcare Company)

  The FDA approved a supplemental application for SELZENTRY (maraviroc) submitted by ViiV Healthcare Company. Details on the specific changes …

• FDA approval · 2008-11-25
  FDA Approved: VIRACEPT — Supplemental Application (AGOURON)

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

• FDA approval · 2008-11-25
  FDA Approved: VIRACEPT — Supplemental Application (AGOURON)

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

• FDA approval · 2008-11-04
  FDA Approved: VIREAD — Supplemental Application (Gilead Sciences, Inc.)

  The FDA approved a supplemental application for VIREAD (tenofovir disoproxil fumarate) submitted by Gilead Sciences, indicating changes to i…

• FDA approval · 2008-10-24
  FDA Approved: ISENTRESS — Supplemental Application (Merck Sharp & Dohme LLC)

  The FDA approved a supplemental application for Isentress (raltegravir) by Merck Sharp & Dohme LLC. The approval updates the product’s indic…

• FDA approval · 2008-10-21
  FDA Approved: PREZISTA — Supplemental Application (Janssen Products LP)

  FDA approved a supplemental application for PREZISTA (darunavir) from Janssen Products LP. This action represents an FDA regulatory update r…