Acquired Immunodeficiency Syndrome

• FDA approval · 2015-06-26
  FDA Approved: ZIDOVUDINE — Supplemental Application (Aurobindo Pharma Limited)

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

• FDA approval · 2015-06-26
  FDA Approved: ZIDOVUDINE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Zidovudine from Aurobindo Pharma Limited (AP). The approval confirms the availability of a gener…

• FDA approval · 2015-06-08
  FDA Approved: MEGESTROL ACETATE — Supplemental Application (Upsher-Smith Laboratories, LLC)

  FDA approved Upsher-Smith Laboratories' supplemental application for Megestrol Acetate (generic megestrol acetate) under ANDA 203139.

• 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 · 2014-07-11
  FDA Approved: TRUVADA — Supplemental Application (Gilead Sciences, Inc)

  The FDA approved a supplemental application for TRUVADA (emtricitabine/tenofovir disoproxil fumarate) to update/expand its labeling.

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• FDA approval · 2013-11-07
  FDA Approved: NORVIR — Supplemental Application (AbbVie Inc.)

  FDA approved AbbVie's supplemental application for NORVIR (ritonavir).

• FDA approval · 2013-10-23
  FDA Approved: TRUVADA — Supplemental Application (Gilead Sciences, Inc)

  The FDA approved a supplemental application for Truvada (emtricitabine and tenofovir disoproxil fumarate) submitted by Gilead Sciences, Inc.

• FDA approval · 2013-07-08
  FDA Approved: TRUVADA — Supplemental Application (Gilead Sciences, Inc)

  The FDA approved a supplemental application for TRUVADA from Gilead Sciences, Inc.

• FDA approval · 2012-10-30
  FDA Approved: ZIDOVUDINE — Supplemental Application (Aurobindo Pharma Limited)

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

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

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

• FDA approval · 2012-05-16
  FDA Approved: KALETRA — Supplemental Application (AbbVie Inc.)

  The FDA approved a supplemental application for KALETRA (lopinavir/ritonavir) by AbbVie. This action approves changes to its labeling or ind…

• FDA approval · 2012-03-28
  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 · 2012-02-28
  FDA Approved: ZIDOVUDINE — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for Zidovudine from Aurobindo Pharma Limited. The approval allows continued marketing of the gen…

• FDA approval · 2012-02-17
  FDA Approved: KALETRA — Supplemental Application (AbbVie Inc.)

  The FDA approved a supplemental application for KALETRA (lopinavir/ritonavir) submitted by AbbVie, resulting in changes to its labeling unde…

• FDA approval · 2012-02-17
  FDA Approved: VIRACEPT — Supplemental Application (AGOURON)

  FDA approved a supplemental application for VIRACEPT (nelfinavir mesylate) by Agouron Pharmaceuticals.

• FDA approval · 2011-12-30
  FDA Approved: ZIDOVUDINE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Zidovudine submitted by Aurobindo Pharma Limited under an ANDA, authorizing changes to the appro…

• FDA approval · 2011-11-18
  FDA Approved: ZIAGEN — Supplemental Application (ViiV Healthcare Company)

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

• FDA approval · 2011-07-08
  FDA Approved: TRUVADA — Supplemental Application (Gilead Sciences, Inc)

  The FDA approved a supplemental application for TRUVADA (emtricitabine and tenofovir disoproxil fumarate) from Gilead Sciences, Inc., relate…

• FDA approval · 2010-06-14
  FDA Approved: ZIDOVUDINE — Supplemental Application (Aurobindo Pharma Limited)

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

• FDA approval · 2009-11-06
  FDA Approved: RETROVIR — Supplemental Application (ViiV Healthcare Company)

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

• 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 · 2009-03-05
  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 · 2008-11-25
  FDA Approved: VIRACEPT — Supplemental Application (AGOURON)

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

• FDA approval · 2008-09-30
  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.

• FDA approval · 2008-09-19
  FDA Approved: RETROVIR — Supplemental Application (ViiV Healthcare Company)

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