Hepatitis B
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Sign up freeTop drugs studied for this disease
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FDA approval · 2017-04-07FDA Approved: VEMLIDY — Supplemental Application (Gilead Sciences, Inc.)
FDA approved a supplemental application for Vemlidy (tenofovir alafenamide) from Gilead Sciences. The action documents regulatory approval o…
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FDA approval · 2016-12-07FDA Tentative Approval: TENOFOVIR DISOPROXIL FUMARATE — Supplemental Application (Strides Pharma Science Limited)
FDA granted tentative approval for Strides Pharma Science Limited's generic Tenofovir Disoproxil Fumarate. The product is considered bioequi…
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FDA approval · 2016-12-06FDA Approved: ENTECAVIR — Original Application (NorthStar RxLLC)
The FDA approved NorthStar RxLLC's original ANDA for entecavir, a generic antiviral for chronic hepatitis B.
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FDA approval · 2016-11-21FDA Approved: LAMIVUDINE — Original Application (Rising Pharma Holdings, Inc.)
FDA approved the original generic application for lamivudine from Rising Pharma Holdings, Inc., making a generic option available for HIV-1 …
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FDA approval · 2016-11-10FDA Approved: VEMLIDY — Original Application (Gilead Sciences, Inc.)
FDA granted original approval to Vemlidy (tenofovir alafenamide) from Gilead Sciences for the treatment of chronic hepatitis B virus infecti…
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FDA approval · 2016-09-30FDA Approved: ENTECAVIR — Supplemental Application (AvKARE)
FDA approved a supplemental application for AvKARE's generic entecavir, authorizing its continued marketing for chronic hepatitis B.
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FDA approval · 2015-11-12FDA Approved: ENTECAVIR — Original Application (AvKARE)
FDA approved AvKARE's original application for entecavir (generic) for chronic hepatitis B.
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FDA approval · 2015-08-26FDA Approved: ENTECAVIR — Original Application (Aurobindo Pharma Limited)
FDA approved Aurobindo Pharma Limited's original application for a generic entecavir, used to treat chronic hepatitis B.
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FDA approval · 2015-08-21FDA Approved: ENTECAVIR — Original Application (Camber Pharmaceuticals, Inc.)
FDA approves Camber Pharmaceuticals' original application for entecavir, a generic antiviral used to treat chronic hepatitis B infection.
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FDA approval · 2014-10-31FDA Approved: LAMIVUDINE — Original Application (Chartwell RX, LLC)
FDA approved the Original Application for Lamivudine oral from Chartwell RX, LLC, a generic lamivudine product. Indications include treatmen…
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FDA approval · 2014-03-20FDA Approved: BARACLUDE — Supplemental Application (E.R. Squibb & Sons, L.L.C.)
The FDA approved a supplemental application for Baraclude (entecavir) from E.R. Squibb & Sons, L.L.C., to modify labeling based on additiona…
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FDA approval · 2014-03-20FDA Approved: BARACLUDE — Supplemental Application (E.R. Squibb & Sons, L.L.C.)
The FDA approved a supplemental application for Baraclude (entecavir) submitted by E.R. Squibb & Sons, L.L.C., resulting in an approved modi…
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CLINICAL_TRIALS approval · 2014-01-07Clinical Trial Update: An Open-Label Program of Adefovir Dipivoxil in the Treatment of Patients With Lamivudine-Resistant Chronic Hepatitis B With Limited Treatment Options
Regulatory approval for marketing of adefovir dipivoxil for lamivudine-resistant chronic hepatitis B, expanding treatment options for patien…
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FDA approval · 2014-01-02FDA Approved: LAMIVUDINE — Original Application (Camber Pharmaceuticals, Inc.)
FDA approved Camber Pharmaceuticals' generic lamivudine tablet under an Original Application (ANDA). Lamivudine is used to treat HIV-1 infec…
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FDA approval · 2014-01-02FDA Approved: LAMIVUDINE — Original Application (Apotex Corp.)
FDA approves Apotex Corp.'s original application for a generic lamivudine product (ANDA 202941). The generic is approved for the same indica…
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FDA approval · 2013-12-19FDA Approved: BARACLUDE — Supplemental Application (E.R. Squibb & Sons, L.L.C.)
FDA approved a supplemental application for Baraclude (entecavir) by E.R. Squibb & Sons, L.L.C. The approval updates the product labeling to…
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FDA approval · 2013-12-19FDA Approved: BARACLUDE — Supplemental Application (E.R. Squibb & Sons, L.L.C.)
FDA approved a supplemental application for BARACLUDE (entecavir) submitted by E.R. Squibb & Sons, L.L.C.
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FDA approval · 2013-08-29FDA Approved: ADEFOVIR DIPIVOXIL — Original Application (Sigmapharm Laboratories, LLC)
FDA approved the original ANDA for Adefovir dipivoxil from Sigmapharm Laboratories, LLC, enabling generic manufacture of this antiviral for …
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FDA approval · 2013-06-18FDA Approved: BARACLUDE — Supplemental Application (E.R. Squibb & Sons, L.L.C.)
The FDA approved a supplemental application for BARACLUDE (entecavir) submitted by E.R. Squibb & Sons, L.L.C.
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FDA approval · 2013-04-16FDA Approved: BARACLUDE — Supplemental Application (E.R. Squibb & Sons, L.L.C.)
FDA approved a supplemental application for BARACLUDE (entecavir) submitted by E.R. Squibb & Sons, L.L.C.
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FDA approval · 2012-10-12FDA Approved: BARACLUDE — Supplemental Application (E.R. Squibb & Sons, L.L.C.)
The FDA approved a supplemental application for Baraclude (entecavir) submitted by E.R. Squibb & Sons, L.L.C., representing an additional ap…
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FDA approval · 2011-12-02FDA Approved: LAMIVUDINE — Original Application (Apotex Corp.)
FDA approves Apotex Corp.'s original application for lamivudine (generic), authorizing its marketing for HIV-1 infection and chronic hepatit…
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FDA approval · 2010-12-28FDA Approved: BARACLUDE — Supplemental Application (E.R. Squibb & Sons, L.L.C.)
The FDA approved a supplemental application for BARACLUDE (entecavir) submitted by E.R. Squibb & Sons, L.L.C.
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FDA approval · 2010-12-28FDA Approved: BARACLUDE — Supplemental Application (E.R. Squibb & Sons, L.L.C.)
The FDA approved a supplemental application for Baraclude (entecavir) submitted by E.R. Squibb & Sons, L.L.C.
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FDA approval · 2010-10-15FDA Approved: BARACLUDE — Supplemental Application (E.R. Squibb & Sons, L.L.C.)
FDA approved a supplemental application for BARACLUDE (entecavir) submitted by E.R. Squibb & Sons, L.L.C.