HIV Infection

• FDA approval · 2012-05-22
  FDA Approved: NEVIRAPINE — Original Application (Aurobindo Pharma Limited)

  FDA approved a generic nevirapine product from Aurobindo Pharma Limited under an Original Application for the treatment of HIV infection.

• FDA approval · 2012-05-22
  FDA Approved: NEVIRAPINE — Original Application (Amneal Pharmaceuticals LLC)

  FDA approved the original application (ANDA) for NEVIRAPINE, a generic antiretroviral agent, manufactured by Amneal Pharmaceuticals LLC. Thi…

• FDA approval · 2012-05-22
  FDA Approved: NEVIRAPINE — Original Application (Aurobindo Pharma Limited)

  FDA approved Aurobindo Pharma Limited's generic nevirapine under an Original Application (ANDA077521). It is indicated for HIV-1 infection a…

• FDA approval · 2012-05-18
  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 · 2012-05-16
  FDA Approved: KALETRA — Supplemental Application (AbbVie Inc.)

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

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• 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 · 2012-04-20
  FDA Approved: KALETRA — Supplemental Application (AbbVie Inc.)

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

• FDA approval · 2012-04-20
  FDA Approved: KALETRA — Supplemental Application (AbbVie Inc.)

  The FDA approved AbbVie’s supplemental application for KALETRA (lopinavir/ritonavir). The approval updates the product labeling related to i…

• FDA approval · 2012-04-18
  FDA Approved: ISENTRESS — Supplemental Application (Merck Sharp & Dohme LLC)

  FDA approves a supplemental application for Isentress (raltegravir) submitted by Merck Sharp & Dohme LLC.

• FDA approval · 2012-04-18
  FDA Approved: ISENTRESS — Supplemental Application (Merck Sharp & Dohme LLC)

  FDA approved a supplemental application for ISENTRESS (raltegravir) submitted by Merck Sharp & Dohme LLC. This action confirms FDA approval …

• FDA approval · 2012-04-06
  FDA Approved: VIRACEPT — Supplemental Application (AGOURON)

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

• FDA approval · 2012-04-06
  FDA Approved: VIRACEPT — Supplemental Application (AGOURON)

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

• 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 · 2012-03-26
  FDA Approved: ETRAVIRINE — Supplemental Application (Patriot Pharmaceuticals)

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

• FDA approval · 2012-03-15
  FDA Approved: ZIAGEN — Supplemental Application (ViiV Healthcare Company)

  FDA approves a supplemental application for ZIAGEN (abacavir sulfate) filed by ViiV Healthcare Company. The action relates to the drug's lab…

• FDA approval · 2012-03-14
  FDA Approved: REYATAZ — Supplemental Application (E.R. Squibb & Sons, L.L.C.)

  The FDA approved a supplemental application for Reyataz (atazanavir) filed by E.R. Squibb & Sons, L.L.C., resulting in a labeling/indication…

• FDA approval · 2012-03-06
  FDA Approved: ZIDOVUDINE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Zidovudine from Aurobindo Pharma Limited, enabling continued approval of a generic Zidovudine pr…

• 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: PREZISTA — Supplemental Application (Janssen Products LP)

  FDA approves a supplemental NDA for PREZISTA (darunavir) from Janssen Products LP.

• FDA approval · 2012-02-17
  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.

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

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

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

  The FDA approved a supplemental application for Norvir (ritonavir) submitted by AbbVie Inc., resulting in an approved update to the drug's l…

• FDA approval · 2012-02-17
  FDA Approved: PREZISTA — Supplemental Application (Janssen Products LP)

  FDA approved a supplemental application for Prezista (darunavir) from Janssen Products LP, expanding its approved use in HIV-1 infection.