Cytomegalovirus Retinitis
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Sign up freeTop drugs studied for this disease
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FDA approval · 2017-12-12FDA Approved: VALGANCICLOVIR HYDROCHLORIDE — Original Application (Dr. Reddy's Laboratories Inc)
FDA approves valganciclovir hydrochloride as an original generic drug via ANDA 206876 from Dr. Reddy's Laboratories Inc.
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CLINICAL_TRIALS trial_result · 2017-05-17Clinical Trial Update: A Comparison of Valganciclovir and Ganciclovir in the Treatment of Cytomegalovirus (CMV) of the Eyes [Phase 3]
A Phase 3 trial comparing valganciclovir with ganciclovir for the treatment of cytomegalovirus retinitis in HIV-infected patients has comple…
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FDA approval · 2017-02-24FDA Approved: FOSCAVIR — Supplemental Application (Clinigen Limited)
The FDA approved a supplemental application for FOSCAVIR (foscarnet sodium) submitted by Clinigen Limited. The approval reflects an update r…
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FDA approval · 2016-12-06FDA Approved: GANCICLOVIR — Original Application (Endo USA, Inc.)
FDA approves Endo USA's ganciclovir as a generic product under an Original Application, enabling marketing of a generic form of ganciclovir.
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FDA approval · 2016-11-10FDA Approved: FOSCAVIR — Supplemental Application (Clinigen Limited)
The FDA approved a supplemental application for FOSCAVIR (foscarnet sodium) submitted by Clinigen Limited.
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FDA approval · 2016-07-18FDA Approved: VALGANCICLOVIR HYDROCHLORIDE FOR ORAL — Original Application (Actavis Pharma, Inc.)
FDA approved an oral valganciclovir hydrochloride product from Actavis Pharma (Original Application) for prevention and treatment of cytomeg…
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FDA approval · 2016-04-28FDA Approved: VALGANCICLOVIR — Supplemental Application (Strides Pharma Science Limited)
FDA approved a supplemental application for valganciclovir hydrochloride (valganciclovir) by Strides Pharma Science Limited, a generic versi…
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FDA approval · 2016-03-31FDA Approved: VALGANCICLOVIR HYDROCHLORIDE — Original Application (NorthStar Rx LLC)
FDA approved an original application for valganciclovir hydrochloride (generic) to be marketed by NorthStar Rx LLC.
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FDA approval · 2016-03-18FDA Approved: VALGANCICLOVIR — Original Application (Camber Pharmaceuticals, Inc.)
The FDA approved Camber Pharmaceuticals’ original application for valganciclovir, enabling a generic version of the antiviral.
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CLINICAL_TRIALS trial_result · 2016-03-14Clinical Trial Update: Studies of Ocular Complications of AIDS (SOCA)--Ganciclovir-Cidofovir CMV Retinitis Trial (GCCRT) [Phase 3]
Phase 3 study evaluating ganciclovir and cidofovir for CMV retinitis in AIDS patients; the trial is completed and results were posted in 201…
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CLINICAL_TRIALS trial_result · 2015-11-17Clinical Trial Update: Studies of the Ocular Complications of AIDS (SOCA)--HPMPC Peripheral CMV Retinitis Trial (HPCRT) [Phase 2, Phase 3]
Clinical trial update for the SOCA HPCRT study evaluating HPMPC (cidofovir) for CMV retinitis in HIV/AIDS patients; the Phase 2/Phase 3 tria…
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CLINICAL_TRIALS trial_result · 2015-11-17Clinical Trial Update: Studies of the Ocular Complications of AIDS (SOCA)--Monoclonal Antibody CMV Retinitis Trial (MACRT) [Phase 2, Phase 3]
Phase 2/3 trial evaluating a CMV-specific monoclonal antibody for ocular complications in AIDS patients with Cytomegalovirus retinitis; resu…
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CLINICAL_TRIALS trial_result · 2015-10-22Clinical Trial Update: Studies of the Ocular Complications of AIDS (SOCA)--Foscarnet-Ganciclovir CMV Retinitis Trial (FGCRT) [Phase 3]
Phase 3 clinical trial update for FGCRT evaluating combination therapy with Foscarnet and Ganciclovir for CMV retinitis in individuals with …
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CLINICAL_TRIALS trial_result · 2015-09-14Clinical Trial Update: Studies of the Ocular Complications of AIDS (SOCA)--Cytomegalovirus Retinitis Retreatment Trial (CRRT) [Phase 3]
Phase 3 trial update from the SOCA studies on Cytomegalovirus retinitis retreatment in HIV/AIDS patients; results for the CRRT have been pos…
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FDA approval · 2015-07-14FDA Approved: VALCYTE — Supplemental Application (H2-Pharma, LLC)
FDA approved a supplemental application for VALCYTE (valganciclovir hydrochloride) submitted by H2-Pharma, LLC.
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CLINICAL_TRIALS trial_result · 2015-06-12Clinical Trial Update: Longitudinal Study of Ocular Complications of AIDS (LSOCA)
This entry notes that the Longitudinal Study of Ocular Complications of AIDS (LSOCA) sponsored by Johns Hopkins has completed.
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FDA approval · 2015-05-29FDA Approved: FOSCAVIR — Supplemental Application (Clinigen Limited)
The FDA approves a supplemental application for FOSCAVIR (foscarnet sodium) filed by Clinigen Limited.
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FDA approval · 2015-04-23FDA Approved: VALCYTE — Supplemental Application (H2-Pharma, LLC)
FDA approves a supplemental application for VALCYTE (valganciclovir hydrochloride) submitted by H2-Pharma, LLC.
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EMA withdrawal · 2015-01-19EMA Withdrawn: Vistide (cidofovir) — Gilead Sciences International Limited
Vistide (cidofovir) has been withdrawn from the European market by the marketing authorization holder Gilead Sciences International Limited.
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FDA approval · 2014-11-04FDA Approved: VALGANCICLOVIR — Original Application (Strides Pharma Science Limited)
The FDA approved Strides Pharma Science Limited's original application for valganciclovir hydrochloride as a generic drug (Valganciclovir).
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CLINICAL_TRIALS trial_result · 2013-06-05Clinical Trial Update: Pharmacokinetics of Cidofovir During Continuous Venovenous Hemofiltration [Phase 4]
A Phase 4 study assessing cidofovir pharmacokinetics during continuous venovenous hemofiltration in patients with cytomegalovirus retinitis …
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CLINICAL_TRIALS trial_result · 2012-11-01Clinical Trial Update: HPMPC (Cidofovir) Peripheral CMV Retinitis Trial Protocol [NA]
This entry notes completion of a clinical trial protocol evaluating cidofovir (HPMPC) for peripheral cytomegalovirus retinitis in HIV-infect…
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CLINICAL_TRIALS trial_result · 2012-10-25Clinical Trial Update: A Phase II/III Trial of Human Anti-CMV Monoclonal Antibody MSL 109 (MACRT) [Phase 2]
This document provides an update on a Phase II/III trial evaluating the human anti-CMV monoclonal antibody MSL-109 (MACRT) for cytomegalovir…
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FDA approval · 2012-06-27FDA Approved: CIDOFOVIR — Original Application (Mylan Institutional LLC)
FDA approved the original application for cidofovir anhydrous (CIDOFOVIR) from Mylan Institutional LLC, indicating a generic version of cido…
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FDA approval · 2012-02-10FDA Approved: FOSCAVIR — Supplemental Application (Clinigen Limited)
FDA approved a supplemental application for FOSCAVIR (foscarnet sodium) submitted by Clinigen Limited.