HIV Infection

• EMA approval · 2024-07-26
  EMA Authorised: Prezista (darunavir) — Janssen-Cilag International NV

  EMA authorised Prezista (darunavir) for HIV infections, with the decision dated 24 July 2024.

• FDA approval · 2024-07-25
  FDA Approved: LOPINAVIR AND RITONAVIR — Original Application (Macleods Pharmaceuticals Limited)

  FDA approves Macleods Pharmaceuticals' original application for Lopinavir and Ritonavir, a generic version of the HIV-1 protease inhibitor c…

• FDA approval · 2024-07-17
  FDA Approved: SUNLENCA — Supplemental Application (Gilead Sciences, Inc.)

  The FDA approved a supplemental application for Sunlenca (lenacapavir sodium) from Gilead Sciences, expanding its labeling.

• FDA approval · 2024-07-17
  FDA Approved: SUNLENCA — Supplemental Application (Gilead Sciences, Inc.)

  The FDA approved a supplemental application for SUNLENCA (lenacapavir sodium) from Gilead Sciences, Inc. This action supports changes throug…

• FDA approval · 2024-06-21
  FDA Approved: ATAZANAVIR SULFATE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for atazanavir sulfate from Aurobindo Pharma Limited, effectively approving this generic HIV proteas…

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• FDA approval · 2024-06-21
  FDA Approved: ATAZANAVIR — Supplemental Application (Laurus Labs Limited)

  FDA approved a supplemental application for atazanavir submitted by Laurus Labs Limited (ANDA 212579).

• FDA approval · 2024-06-20
  FDA Approved: EFAVIRENZ — Supplemental Application (Aurobindo Pharma Limited)

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

• FDA approval · 2024-06-18
  FDA Approved: EFAVIRENZ — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for EFAVIRENZ from Aurobindo Pharma Limited, authorizing changes to the approved ANDA product (s…

• FDA approval · 2024-06-14
  FDA Approved: ABACAVIR AND LAMIVUDINE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' supplemental application for a generic fixed-dose combination of abacavir and lamivudine for the treatme…

• FDA approval · 2024-06-04
  FDA Approved: RETACRIT — Supplemental Application (Vifor (International) Inc.)

  The FDA approved a supplemental application for RETACRIT (epoetin alfa-epbx) submitted by Vifor (International) Inc.

• FDA approval · 2024-05-23
  FDA Approved: NEVIRAPINE — Supplemental Application (Micro Labs Limited)

  FDA approved a supplemental application for nevirapine from Micro Labs Limited, enabling the availability of a generic nevirapine product fo…

• FDA approval · 2024-05-10
  FDA Approved: EFAVIRENZ — Original Application (Macleods Pharmaceuticals Limited)

  FDA approved the generic efavirenz from Macleods Pharmaceuticals Limited under ANDA 091579. This action grants regulatory approval for the g…

• FDA approval · 2024-04-24
  FDA Approved: BIKTARVY — Supplemental Application (Gilead Sciences, Inc.)

  FDA approved a supplemental application for BIKTARVY (bictegravir, emtricitabine, and tenofovir alafenamide) from Gilead Sciences, for its H…

• FDA approval · 2024-04-18
  FDA Approved: TIVICAY — Supplemental Application (ViiV Healthcare Company)

  The FDA approved a supplemental application for Tivicay (dolutegravir) submitted by ViiV Healthcare Company.

• FDA approval · 2024-04-18
  FDA Approved: DOVATO — Supplemental Application (ViiV Healthcare Company)

  The FDA approved a supplemental application for DOVATO (dolutegravir and lamivudine) from ViiV Healthcare Company to update the drug’s label…

• FDA approval · 2024-04-18
  FDA Approved: TIVICAY PD — Supplemental Application (ViiV Healthcare Company)

  The FDA has approved a supplemental application for Tivicay PD (dolutegravir) from ViiV Healthcare Company.

• FDA approval · 2024-04-18
  FDA Approved: JULUCA — Supplemental Application (ViiV Healthcare Company)

  The FDA approved a supplemental application for JULUCA (dolutegravir and rilpivirine) submitted by ViiV Healthcare Company.

• FDA approval · 2024-04-05
  FDA Approved: DOVATO — Supplemental Application (ViiV Healthcare Company)

  FDA approved a supplemental application for DOVATO (dolutegravir and lamivudine) from ViiV Healthcare Company.

• FDA approval · 2024-04-03
  FDA Approved: APTIVUS — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for APTIVUS (tipranavir) from Boehringer Ingelheim Pharmaceuticals, Inc., updating the drug’s la…

• FDA approval · 2024-04-03
  FDA Approved: MYTESI — Supplemental Application (Napo Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Mytesi (crofelemer) from Napo Pharmaceuticals, confirming/expanding its regulatory approval …

• FDA approval · 2024-03-28
  FDA Approved: ABACAVIR — Supplemental Application (Cipla USA Inc.)

  The FDA approved a supplemental application for Abacavir submitted by Cipla USA Inc.

• FDA approval · 2024-03-28
  FDA Approved: ABACAVIR — Supplemental Application (Rising Pharma Holdings, Inc.)

  The FDA approved a supplemental application for abacavir sulfate filed by Rising Pharma Holdings, Inc.

• FDA approval · 2024-03-21
  FDA Approved: NEVIRAPINE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for Nevirapine from Mylan Pharmaceuticals Inc., resulting in a generic Nevirapine product under the …

• FDA approval · 2024-03-15
  FDA Approved: EDURANT PED — Original Application (Janssen Products, LP)

  FDA approved EDURANT PED (rilpivirine hydrochloride) for HIV-1 infection in pediatric patients, establishing the original pediatric indicati…

• FDA approval · 2024-03-15
  FDA Approved: EDURANT — Supplemental Application (Janssen Products, LP)

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