HIV Infection

• FDA approval · 2011-05-20
  FDA Approved: EDURANT — Original Application (Janssen Products, LP)

  The FDA approved the original application for Edurant (rilpivirine hydrochloride) from Janssen, introducing this HIV-1 antiretroviral agent …

• FDA approval · 2011-05-19
  FDA Approved: ZIDOVUDINE — Supplemental Application (Aurobindo Pharma Limited)

  FDA granted approval of a supplemental application for Zidovudine submitted by Aurobindo Pharma Limited. Zidovudine is an antiretroviral use…

• FDA approval · 2011-05-13
  FDA Approved: ZIAGEN — Supplemental Application (ViiV Healthcare Company)

  FDA approved a supplemental application for Ziagen (abacavir sulfate) filed by ViiV Healthcare Company.

• FDA approval · 2011-05-06
  FDA Approved: KALETRA — Supplemental Application (AbbVie Inc.)

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

• FDA approval · 2011-04-05
  FDA Approved: APTIVUS — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Aptivus (tipranavir) submitted by Boehringer Ingelheim Pharmaceuticals, Inc. The action approves…

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• FDA approval · 2011-02-25
  FDA Approved: VIRACEPT — Supplemental Application (AGOURON)

  The FDA approved a supplemental application for Viracept (nelfinavir mesylate) submitted by Agouron, updating the approved labeling for the …

• FDA approval · 2011-02-25
  FDA Approved: VIRACEPT — Supplemental Application (AGOURON)

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

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

  The FDA approved a supplemental application for KALETRA (lopinavir/ritonavir) from AbbVie, updating the product labeling for HIV infection.

• FDA approval · 2011-02-24
  FDA Approved: ISENTRESS — Supplemental Application (Merck Sharp & Dohme LLC)

  FDA approved a supplemental application for Isentress (raltegravir) from Merck Sharp & Dohme LLC. The action approves changes to the labelin…

• FDA approval · 2011-02-04
  FDA Approved: REYATAZ — Supplemental Application (E.R. Squibb & Sons, L.L.C.)

  FDA approved a supplemental application for Reyataz (atazanavir) submitted by E.R. Squibb & Sons, L.L.C., authorizing a modification or addi…

• FDA approval · 2010-12-22
  FDA Approved: ETRAVIRINE — Supplemental Application (Patriot Pharmaceuticals)

  The FDA approved a supplemental application for ETRAVIRINE submitted by Patriot Pharmaceuticals.

• FDA approval · 2010-12-17
  FDA Approved: ETRAVIRINE — Supplemental Application (Patriot Pharmaceuticals)

  FDA approved a supplemental application for ETRAVIRINE from Patriot Pharmaceuticals.

• FDA approval · 2010-12-13
  FDA Approved: PREZISTA — Supplemental Application (Janssen Products LP)

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

• FDA approval · 2010-11-04
  FDA Approved: ZIDOVUDINE — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for Zidovudine by Aurobindo Pharma Limited for an existing Zidovudine product.

• FDA approval · 2010-11-04
  FDA Approved: ZIDOVUDINE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Zidovudine by Aurobindo Pharma Limited, granting continued approval for this generic HIV drug.

• FDA approval · 2010-10-01
  FDA Approved: COMBIVIR — Supplemental Application (ViiV Healthcare Company)

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

• FDA approval · 2010-08-24
  FDA Approved: ZIDOVUDINE — Supplemental Application (Aurobindo Pharma Limited)

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

• FDA approval · 2010-08-16
  FDA Approved: APTIVUS — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for APTIVUS (tipranavir) from Boehringer Ingelheim Pharmaceuticals, Inc. The action involves cha…

• FDA approval · 2010-08-04
  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 · 2010-06-29
  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 · 2010-06-14
  FDA Approved: KALETRA — Supplemental Application (AbbVie Inc.)

  The FDA approved a supplemental application for KALETRA (lopinavir/ritonavir) submitted by AbbVie Inc. This action updates the regulatory st…

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

  FDA granted a supplemental approval for Zidovudine manufactured by Aurobindo Pharma Limited.

• FDA approval · 2010-06-14
  FDA Approved: KALETRA — Supplemental Application (AbbVie Inc.)

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

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

  FDA approved a supplemental application for Zidovudine from Aurobindo Pharma Limited, confirming the approval of this generic Zidovudine pro…