HIV Infection
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Sign up freeTop drugs studied for this disease
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FDA approval · 2018-04-18FDA 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.
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FDA approval · 2018-04-18FDA 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. The action updates the current appr…
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FDA approval · 2018-04-09FDA Approved: EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE — Original Application (Mylan Pharmaceuticals Inc.)
The FDA approved the original application for a generic fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, manufactu…
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FDA approval · 2018-03-22FDA Approved: SYMFI — Original Application (Viatris Specialty LLC)
The FDA approved Symfi, a fixed-dose combination tablet of efavirenz, lamivudine, and tenofovir disoproxil fumarate, under NDA 022142 by Via…
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FDA approval · 2018-03-14FDA Approved: ABACAVIR — Original Application (Rising Pharma Holdings, Inc.)
FDA approved the original application for abacavir sulfate (abacavir) as a generic drug. Rising Pharma Holdings, Inc. is the manufacturer.
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FDA approval · 2018-03-06FDA Approved: TROGARZO — Original Application (Theratechnologies Inc.)
The FDA approved TROGARZO (ibalizumab) as the original application for treatment of adults with multidrug-resistant HIV-1 infection who are …
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FDA approval · 2018-03-06FDA Approved: MYTESI — Supplemental Application (Napo Pharmaceuticals, Inc.)
FDA approves a supplemental application for Mytesi (crofelemer) submitted by Napo Pharmaceuticals, Inc. This action approves the supplementa…
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FDA approval · 2018-03-05FDA Approved: ISENTRESS — Supplemental Application (Merck Sharp & Dohme LLC)
The FDA approved a supplemental application for Isentress (raltegravir) submitted by Merck Sharp & Dohme LLC.
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FDA approval · 2018-03-05FDA Approved: ISENTRESS — Supplemental Application (Merck Sharp & Dohme LLC)
The FDA approved a supplemental application for Isentress (raltegravir) by Merck Sharp & Dohme LLC, updating the drug's labeling per the sup…
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FDA approval · 2018-03-05FDA Approved: ISENTRESS — Supplemental Application (Merck Sharp & Dohme LLC)
FDA approved a supplemental application for ISENTRESS (raltegravir) from Merck Sharp & Dohme LLC.
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FDA approval · 2018-03-02FDA Approved: TENOFOVIR DISOPROXIL FUMARATE — Original Application (Quinn Pharmaceuticals)
FDA approves an original ANDA for a generic tenofovir disoproxil fumarate from Quinn Pharmaceuticals for the treatment of HIV infection and …
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FDA approval · 2018-02-28FDA Approved: CIMDUO — Original Application (Viatris Specialty LLC)
FDA approved CIMDUO, a fixed-dose combination of lamivudine and tenofovir disoproxil fumarate, in an original application by Viatris Special…
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FDA approval · 2018-02-07FDA Approved: BIKTARVY — Original Application (Gilead Sciences, Inc.)
FDA approved Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) as a single-tablet regimen for the treatment of HIV-1 infection in a…
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FDA approval · 2018-02-01FDA Approved: EDURANT — Supplemental Application (Janssen Products, LP)
FDA approved a supplemental application for EDURANT (rilpivirine hydrochloride) submitted by Janssen Products, LP.
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FDA approval · 2018-01-26FDA Approved: TENOFOVIR DISOPROXIL FUMARATE — Original Application (Strides Pharma Science Limited)
FDA approved the original application for tenofovir disoproxil fumarate as a generic product manufactured by Strides Pharma Science Limited.
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FDA approval · 2018-01-26FDA Approved: TENOFOVIR DISOPROXIL FUMARATE — Original Application (Macleods Pharmaceuticals Limited)
FDA approved Macleods Pharmaceuticals Limited's generic Tenofovir disoproxil fumarate under an Original Application for use in HIV-1 infecti…
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FDA approval · 2018-01-26FDA Approved: EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE — Original Application (QUALLENT PHARMACEUTICALS HEALTH LLC)
FDA approved the original application for emtricitabine and tenofovir disoproxil fumarate as a generic product, manufactured by Quallent Pha…
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FDA approval · 2018-01-26FDA Approved: TENOFOVIR DISOPROXIL FUMARATE — Original Application (Aurobindo Pharma Limited)
FDA approved the original application for Tenofovir disoproxil fumarate from Aurobindo Pharma Limited, authorizing a generic version of the …
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FDA approval · 2018-01-26FDA Approved: TENOFOVIR DISOPROXIL FUMARATE — Original Application (Cipla USA Inc.)
FDA approved the original generic application for tenofovir disoproxil fumarate (Cipla USA Inc.), enabling a generic version of the HIV and …
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FDA approval · 2018-01-25FDA Approved: PREZISTA — Supplemental Application (Janssen Products LP)
The FDA approved a supplemental application for Prezista (darunavir) submitted by Janssen Products LP, resulting in updated labeling for HIV…
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FDA approval · 2018-01-25FDA Approved: PREZCOBIX — Supplemental Application (Janssen Products, LP)
The FDA approved a supplemental application for PREZCOBIX (darunavir ethanolate and cobicistat) submitted by Janssen Products, LP, likely mo…
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FDA approval · 2018-01-25FDA 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 labe…
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FDA approval · 2018-01-17FDA Approved: JULUCA — Supplemental Application (ViiV Healthcare Company)
FDA approved a supplemental application for JULUCA (dolutegravir and rilpivirine) submitted by ViiV Healthcare Company.
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FDA approval · 2017-12-15FDA Approved: EFAVIRENZ — Original Application (Aurobindo Pharma Limited)
The FDA approved an original ANDA for efavirenz (EFAVIRENZ) from Aurobindo Pharma Limited, enabling the marketing of the generic antiretrovi…
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FDA approval · 2017-12-08FDA Approved: TRUVADA — Supplemental Application (Gilead Sciences, Inc)
FDA approved a supplemental application for Truvada (emtricitabine/tenofovir disoproxil fumarate) from Gilead Sciences, Inc.