HIV Infection
📧 Sign up to get email alerts when something new happens for HIV Infection.
Sign up freeTop drugs studied for this disease
-
FDA approval · 2024-03-09FDA Approved: EFAVIRENZ, EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved a supplemental application for Teva's fixed-dose combination of efavirenz, emtricitabine, and tenofovir disoproxil fumarate for…
-
FDA approval · 2024-02-23FDA Approved: BIKTARVY — Supplemental Application (Gilead Sciences, Inc.)
The FDA approved a supplemental application for BIKTARVY (bictegravir, emtricitabine, and tenofovir alafenamide fumarate) submitted by Gilea…
-
FDA approval · 2024-02-13FDA Approved: RUKOBIA — Supplemental Application (ViiV Healthcare Company)
FDA approves a supplemental application for RUKOBIA (fostemsavir tromethamine) from ViiV Healthcare Company.
-
FDA approval · 2024-02-06FDA Approved: EFAVIRENZ — Supplemental Application (Cipla USA Inc.)
The FDA approved a supplemental application for Efavirenz (generic) from Cipla USA Inc. under ANDA 204766.
-
FDA approval · 2023-12-13FDA Approved: VOCABRIA — Supplemental Application (ViiV Healthcare Company)
FDA approved a supplemental application for VOCABRIA (cabotegravir sodium) from ViiV Healthcare Company, representing an additional regulato…
- Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
-
FDA approval · 2023-12-13FDA Approved: CABENUVA — Supplemental Application (ViiV Healthcare Company)
FDA supplemental application for CABENUVA (cabotegravir and rilpivirine) submitted by ViiV Healthcare Company under NDA 212888; this entry d…
-
FDA approval · 2023-12-13FDA Approved: APRETUDE — Supplemental Application (ViiV Healthcare Company)
FDA approved a supplemental application for APRETUDE (cabotegravir) filed by ViiV Healthcare Company, resulting in an updated labeling/indic…
-
FDA approval · 2023-12-13FDA Approved: DARUNAVIR — Original Application (Zydus Lifesciences Limited)
FDA approved the Original Application for generic darunavir (DARUNAVIR) by Zydus Lifesciences Limited for the treatment of HIV-1 infection i…
-
FDA approval · 2023-12-08FDA Tentative Approval: DARUNAVIR — Original Application (Amneal Pharmaceuticals NY LLC)
FDA issued tentative approval for Amneal Pharmaceuticals NY LLC's generic darunavir (DARUNAVIR) under an ANDA, permitting marketing for HIV-…
-
FDA approval · 2023-11-28FDA Approved: DARUNAVIR 600 AND 800 MG — Original Application (Cipla USA Inc.)
FDA approves Cipla USA's generic darunavir tablets in 600 mg and 800 mg strengths under an Original Application for HIV-1 infection.
-
FDA approval · 2023-11-28FDA Approved: DARUNAVIR — Original Application (Aurobindo Pharma Limited)
FDA approved the original application for generic darunavir from Aurobindo Pharma Limited.
-
FDA approval · 2023-11-28FDA Approved: DARUNAVIR — Original Application (Novadoz Pharmaceuticals LLC)
FDA approved the original application for a generic darunavir product by Novadoz Pharmaceuticals LLC for HIV-1 infection.
-
FDA approval · 2023-11-28FDA Approved: DARUNAVIR — Original Application (Dr.Reddys Laboratories Inc)
FDA approved Dr. Reddy's Laboratories' original application for Darunavir, an HIV protease inhibitor used in antiretroviral therapy for HIV …
-
FDA approval · 2023-11-19FDA Approved: DARUNAVIR — Supplemental Application (Lupin Pharmaceuticals, Inc.)
FDA approves Lupin Pharmaceuticals' supplemental application for Darunavir, enabling the sale of a generic darunavir product.
-
FDA approval · 2023-11-07FDA 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. This action constitutes regulatory …
-
FDA approval · 2023-11-07FDA Approved: REYATAZ — Supplemental Application (E.R. Squibb & Sons, L.L.C.)
FDA approved a supplemental application for Reyataz (atazanavir) filed by E.R. Squibb & Sons & L.L.C.
-
FDA approval · 2023-11-03FDA Approved: DOVATO — Supplemental Application (ViiV Healthcare Company)
The FDA approved a supplemental application for DOVATO (dolutegravir and lamivudine) from ViiV Healthcare Company.
-
FDA approval · 2023-10-11FDA Approved: TRUVADA — Supplemental Application (Gilead Sciences, Inc)
The FDA approved a supplemental application for TRUVADA (emtricitabine and tenofovir disoproxil fumarate) from Gilead Sciences, finalizing a…
-
FDA approval · 2023-10-05FDA Approved: LAMIVUDINE — Supplemental Application (Lupin Pharmaceuticals, Inc.)
FDA approved Lupin Pharmaceuticals' supplemental application for lamivudine, resulting in an approved generic lamivudine product. Lamivudine…
-
FDA approval · 2023-09-14FDA Approved: DARUNAVIR — Original Application (Camber Pharmaceuticals, Inc.)
FDA approves Camber Pharmaceuticals' generic darunavir (Darunavir) under an Original Application (ANDA202083) for HIV-1 infection. The appro…
-
FDA approval · 2023-08-17FDA Approved: MARAVIROC — Original Application (i3 Pharmaceuticals, LLC)
FDA approved the original application for maraviroc for treatment of HIV-1 infection.
-
FDA approval · 2023-06-15FDA Approved: TRIUMEQ PD — Supplemental Application (ViiV Healthcare Company)
FDA approves a supplemental application for TRIUMEQ PD, the fixed-dose combination of abacavir sulfate, dolutegravir sodium, and lamivudine,…
-
FDA approval · 2023-06-15FDA Approved: TRIUMEQ — Supplemental Application (ViiV Healthcare Company)
FDA approved a supplemental application for Triumeq, a fixed-dose combination of abacavir sulfate, dolutegravir sodium, and lamivudine, subm…
-
FDA approval · 2023-06-07FDA Approved: ABACAVIR AND LAMIVUDINE — Supplemental Application (Cipla USA Inc.)
FDA approved a supplemental application for the abacavir and lamivudine fixed-dose combination from Cipla USA Inc., updating its labeling fo…
-
FDA approval · 2023-06-07FDA Approved: NEVIRAPINE — Supplemental Application (Macleods Pharmaceuticals Limited)
The FDA approved a supplemental application for Nevirapine from Macleods Pharmaceuticals Limited under ANDA090688.