HIV Infection

• FDA approval · 2019-10-03
  FDA Approved: LAMIVUDINE — Supplemental Application (Apotex Corp.)

  FDA approved a supplemental application for Apotex Corp.'s lamivudine, expanding access to a generic lamivudine product.

• FDA approval · 2019-09-26
  FDA Approved: LAMIVUDINE — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for lamivudine from Aurobindo Pharma Limited. This action relates to the approval of a supplemen…

• FDA approval · 2019-09-26
  FDA Approved: LAMIVUDINE — Supplemental Application (Strides Pharma Science Limited)

  FDA approved a supplemental application for Lamivudine from Strides Pharma Science Limited (ANDA 090457). This action confirms approval of a…

• FDA approval · 2019-09-19
  FDA Approved: PIFELTRO — Supplemental Application (Merck Sharp & Dohme LLC)

  FDA approved a supplemental application for PIFELTRO (doravirine) by Merck Sharp & Dohme LLC.

• FDA approval · 2019-09-19
  FDA Approved: DELSTRIGO — Supplemental Application (Merck Sharp & Dohme LLC)

  The FDA approved a supplemental application for Delstrigo (doravirine/lamivudine/tenofovir disoproxil fumarate) from Merck Sharp & Dohme LLC…

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• FDA approval · 2019-08-29
  FDA Approved: LAMIVUDINE — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approval of a supplemental application for lamivudine by Rising Pharma Holdings, Inc.

• FDA approval · 2019-08-27
  FDA Approved: LAMIVUDINE AND ZIDOVUDINE — Supplemental Application (Aurobindo Pharma Limited)

  FDA has approved a supplemental Abbreviated New Drug Application for Lamivudine and Zidovudine from Aurobindo Pharma Limited, enabling the g…

• FDA approval · 2019-08-21
  FDA Approved: NORVIR — Supplemental Application (AbbVie Inc.)

  The FDA approved a supplemental application for NORVIR (ritonavir) submitted by AbbVie Inc.

• FDA approval · 2019-08-21
  FDA Approved: NEVIRAPINE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved Aurobindo Pharma Limited's supplemental application for nevirapine, expanding the availability of this antiretroviral generic. …

• FDA approval · 2019-08-21
  FDA Approved: KALETRA — Supplemental Application (AbbVie Inc.)

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

• FDA approval · 2019-08-21
  FDA Approved: NEVIRAPINE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for Nevirapine (generic) from Mylan Pharmaceuticals Inc., authorizing a modification to an existing …

• FDA approval · 2019-08-21
  FDA Approved: KALETRA — Supplemental Application (AbbVie Inc.)

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

• FDA approval · 2019-08-21
  FDA Approved: NORVIR — Supplemental Application (AbbVie Inc.)

  The FDA approved AbbVie’s supplemental application for NORVIR (ritonavir). The approval updates the product’s labeling or uses as described …

• FDA approval · 2019-08-16
  FDA Approved: ABACAVIR — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for abacavir sulfate by Rising Pharma Holdings, Inc. This action represents an additional regulatory…

• FDA approval · 2019-08-16
  FDA Approved: ABACAVIR — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for ABACAVIR submitted by Aurobindo Pharma Limited.

• FDA approval · 2019-08-14
  FDA Approved: NEVIRAPINE — Supplemental Application (Macleods Pharmaceuticals Limited)

  The FDA approved a supplemental application for Nevirapine from Macleods Pharmaceuticals Limited.

• FDA approval · 2019-08-02
  FDA Approved: BIKTARVY — Supplemental Application (Gilead Sciences, Inc.)

  The FDA approved a supplemental application for BIKTARVY (bictegravir/emtricitabine/tenofovir alafenamide) submitted by Gilead Sciences, Inc…

• FDA approval · 2019-07-26
  FDA Approved: EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE — Original Application (Laurus Labs Limited)

  FDA approved Laurus Labs Limited's generic emtricitabine and tenofovir disoproxil fumarate tablets under an Original Application (ANDA).

• FDA approval · 2019-07-25
  FDA Approved: ABACAVIR AND LAMIVUDINE — Supplemental Application (Cipla USA Inc.)

  FDA approved a supplemental application from Cipla USA Inc. for abacavir and lamivudine (abacavir/lamivudine).

• FDA approval · 2019-07-10
  FDA Approved: ETRAVIRINE — Supplemental Application (Patriot Pharmaceuticals)

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

• FDA approval · 2019-07-01
  FDA Approved: TRUVADA — Supplemental Application (Gilead Sciences, Inc)

  The FDA approved a supplemental application for TRUVADA (emtricitabine/tenofovir disoproxil fumarate) submitted by Gilead Sciences. The appr…

• FDA approval · 2019-07-01
  FDA Approved: EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for Emtricitabine and Tenofovir Disoproxil Fumarate from Mylan Pharmaceuticals Inc., authorizing the…

• FDA approval · 2019-07-01
  FDA Approved: EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  FDA approved Amneal Pharmaceuticals NY LLC's supplemental application for Emtricitabine and Tenofovir Disoproxil Fumarate.

• FDA approval · 2019-07-01
  FDA Approved: EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approves Teva's supplemental application for the generic fixed-dose combination emtricitabine and tenofovir disoproxil fumarate for the …

• FDA approval · 2019-07-01
  FDA Approved: EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE — Supplemental Application (QUALLENT PHARMACEUTICALS HEALTH LLC)

  The FDA approved a supplemental application for Emtricitabine and Tenofovir Disoproxil Fumarate from Quallent Pharmaceuticals Health LLC. Th…