HIV Infection

• FDA approval · 2013-04-26
  FDA Approved: EDURANT — Supplemental Application (Janssen Products, LP)

  FDA approved a supplemental application for EDURANT (rilpivirine hydrochloride) submitted by Janssen Products, LP.

• FDA approval · 2013-04-24
  FDA Approved: PREZISTA — Supplemental Application (Janssen Products LP)

  FDA approved a supplemental application for Prezista (darunavir) from Janssen Products LP.

• FDA approval · 2013-04-24
  FDA Approved: PREZISTA — Supplemental Application (Janssen Products LP)

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

• FDA approval · 2013-04-19
  FDA Approved: COMPLERA — Supplemental Application (Gilead Sciences, Inc.)

  The FDA approved a supplemental application for COMPLERA (emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil fumarate) from …

• FDA approval · 2013-04-04
  FDA Approved: ISENTRESS — Supplemental Application (Merck Sharp & Dohme LLC)

  The FDA approved a supplemental application for Isentress (raltegravir) from Merck, authorizing changes to its labeling and potentially expa…

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• FDA approval · 2013-04-02
  FDA Approved: EMTRIVA — Supplemental Application (Gilead Sciences, Inc.)

  FDA approved a supplemental application for EMTRIVA (emtricitabine) submitted by Gilead Sciences.

• FDA approval · 2013-04-02
  FDA Approved: EMTRIVA — Supplemental Application (Gilead Sciences, Inc.)

  The FDA approved a supplemental application for Emtriva (emtricitabine) submitted by Gilead Sciences, Inc.

• FDA approval · 2013-03-26
  FDA Approved: COMPLERA — Supplemental Application (Gilead Sciences, Inc.)

  FDA approves a supplemental application for COMPLERA submitted by Gilead Sciences, supporting updates to its labeling for the HIV-1 treatmen…

• FDA approval · 2013-03-20
  FDA Approved: NEVIRAPINE — Supplemental Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals' supplemental application for Nevirapine, signaling an approved modification to the product's regulatory…

• FDA approval · 2013-02-27
  FDA Approved: ETRAVIRINE — Supplemental Application (Patriot Pharmaceuticals)

  FDA approves a supplemental NDA for Etravirine submitted by Patriot Pharmaceuticals.

• FDA approval · 2013-02-22
  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 changes to the p…

• FDA approval · 2013-02-16
  FDA Approved: NEBUPENT — Supplemental Application (Fresenius Kabi USA, LLC)

  The FDA approved a supplemental application for NebuPent (pentamidine isethionate) by Fresenius Kabi USA, LLC, to modify the existing approv…

• FDA approval · 2013-02-15
  FDA Approved: STRIBILD — Supplemental Application (Gilead Sciences, Inc.)

  FDA approved a supplemental application for STRIBILD (elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate) from Gilea…

• FDA approval · 2013-02-14
  FDA Approved: SELZENTRY — Supplemental Application (ViiV Healthcare Company)

  The FDA approved a supplemental application for Selzentry (maraviroc) submitted by ViiV Healthcare Company.

• FDA approval · 2013-02-04
  FDA Approved: NEVIRAPINE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for NEVIRAPINE from Aurobindo Pharma Limited, authorizing an additional regulatory action on this ge…

• FDA approval · 2013-02-01
  FDA Approved: PREZISTA — Supplemental Application (Janssen Products LP)

  The FDA approved a supplemental application for Prezista (darunavir) submitted by Janssen Products LP. The approval updates the product's la…

• FDA approval · 2013-02-01
  FDA Approved: SELZENTRY — Supplemental Application (ViiV Healthcare Company)

  The FDA approved a supplemental application for SELZENTRY (maraviroc) submitted by ViiV Healthcare Company. The action updates or expands th…

• FDA approval · 2013-02-01
  FDA Approved: NEVIRAPINE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Nevirapine from Aurobindo Pharma Limited under an ANDA, confirming regulatory approval of a gene…

• FDA approval · 2013-01-30
  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. The approval concerns HIV infec…

• FDA approval · 2013-01-25
  FDA Approved: COMPLERA — Supplemental Application (Gilead Sciences, Inc.)

  The FDA approved a supplemental application for COMPLERA (emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil fumarate) filed…

• FDA approval · 2013-01-17
  FDA Approved: KALETRA — Supplemental Application (AbbVie Inc.)

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

• FDA approval · 2013-01-17
  FDA Approved: KALETRA — Supplemental Application (AbbVie Inc.)

  FDA approves a supplemental application for KALETRA (lopinavir/ritonavir) submitted by AbbVie, updating labeling.

• FDA approval · 2012-12-31
  FDA Approved: MYTESI — Original Application (Napo Pharmaceuticals, Inc.)

  FDA approved the original application for MYTESI (crofelemer) by Napo Pharmaceuticals for relief of non-infectious diarrhea in adults with H…

• FDA approval · 2012-12-18
  FDA Approved: EPIVIR — Supplemental Application (ViiV Healthcare Company)

  The FDA approved a supplemental application for EPIVIR (lamivudine) submitted by ViiV Healthcare Company. The approval updates the labeling …

• FDA approval · 2012-12-17
  FDA Approved: ABACAVIR — Original Application (Aurobindo Pharma Limited)

  FDA approved ABACAVIR from Aurobindo Pharma Limited under an Original Application (ANDA). This provides a generic option for treatment of HI…