Cytomegalovirus Retinitis
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Sign up freeTop drugs studied for this disease
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FDA approval · 2024-03-01FDA Approved: FOSCARNET SODIUM — Original Application (Amneal Pharmaceuticals LLC)
FDA approved the original ANDA for Foscarnet sodium from Amneal Pharmaceuticals LLC.
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FDA approval · 2024-02-15FDA Approved: GANCICLOVIR — Supplemental Application (Pharmascience Inc.)
FDA approved Pharmascience Inc.'s supplemental application for ganciclovir sodium, allowing its continued marketing as a generic antiviral.
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FDA approval · 2023-11-29FDA Approved: FOSCARNET SODIUM — Original Application (Hikma Pharmaceuticals USA Inc.)
FDA approved the original application for Foscarnet Sodium, a generic antiviral intended for CMV and acyclovir-resistant HSV infections.
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FDA approval · 2023-06-05FDA Approved: FOSCARNET SODIUM — Original Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)
The FDA approved the original application for Foscarnet Sodium (generic foscarnet) from Heritage Pharmaceuticals/Avet Pharmaceuticals, enabl…
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FDA approval · 2023-04-11FDA Approved: VALGANCICLOVIR — Original Application (Florida Pharmaceutical Products, LLC)
FDA approved the original application for valganciclovir from Florida Pharmaceutical Products, LLC, authorizing the generic drug product for…
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FDA approval · 2022-10-04FDA Approved: VALGANCICLOVIR — Original Application (Camber Pharmaceuticals, Inc.)
FDA approved Camber Pharmaceuticals' generic valganciclovir hydrochloride under an original ANDA (ANDA 211475), adding a generic option for …
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FDA approval · 2022-08-22FDA Approved: VALGANCICLOVIR — Supplemental Application (Ajanta Pharma USA Inc.)
FDA approved a supplemental application for valganciclovir from Ajanta Pharma USA Inc., confirming regulatory approval of a generic valganci…
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FDA approval · 2022-06-29FDA Approved: VALGANCICLOVIR HYDROCHLORIDE — Supplemental Application (Somerset Therapeutics, LLC)
The FDA approved a supplemental application to Somerset Therapeutics, LLC for valganciclovir hydrochloride (valganciclovir), authorizing a g…
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FDA approval · 2022-02-17FDA Approved: VALGANCICLOVIR — Original Application (airis PHARMA PVT LTD)
FDA approves the original application for valganciclovir from airis PHARMA PVT LTD, enabling a generic version of the antiviral for cytomega…
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CLINICAL_TRIALS trial_result · 2021-11-04Clinical Trial Update: The Safety and Effectiveness of Ganciclovir in the Prevention of Cytomegalovirus (CMV) of the Eyes and Disease of the Stomach and Intestines in Patients With HIV [Phase 2]
Phase 2 trial assessing safety and effectiveness of ganciclovir for CMV-related eye and GI diseases in HIV patients; study completed.
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CLINICAL_TRIALS trial_result · 2021-11-03Clinical Trial Update: A Phase II Dose-Ranging, Open-Labelled Trial of Foscarnet Salvage Therapy for AIDS Patients With Sight-Threatening CMV Retinitis Who Cannot Be Treated With Ganciclovir Due To Myelosuppression or Treatment Failure [Phase 2]
Phase II dose-ranging, open-label trial evaluating foscarnet salvage therapy for AIDS patients with sight-threatening CMV retinitis who cann…
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CLINICAL_TRIALS trial_result · 2021-11-01Clinical Trial Update: Comparison of Two Methods in the Treatment of Cytomegalovirus of the Eyes in Patients With AIDS [Phase 2]
Phase 2 clinical trial comparing two treatment methods for cytomegalovirus retinitis in AIDS patients; study completed.
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FDA approval · 2021-04-21FDA Approved: FOSCARNET SODIUM — Original Application (Gland Pharma Limited)
FDA approved the original application for a generic foscarnet sodium product manufactured by Gland Pharma Limited.
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FDA approval · 2020-11-24FDA 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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FDA approval · 2020-10-28FDA Approved: FOSCAVIR — Supplemental Application (Clinigen Limited)
FDA approved a supplemental application for FOSCAVIR (foscarnet sodium) submitted by Clinigen Limited.
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FDA approval · 2020-06-08FDA Approved: GANCICLOVIR — Supplemental Application (Fresenius Kabi USA, LLC)
The FDA approved a supplemental application for GANCICLOVIR SODIUM from Fresenius Kabi USA, LLC. This action approves a generic version of g…
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FDA approval · 2020-06-08FDA Approved: GANCICLOVIR — Supplemental Application (Endo USA, Inc.)
FDA approved a supplemental application for ganciclovir from Endo USA, Inc., indicating an approved change to the product under the ANDA.
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FDA approval · 2020-03-12FDA Approved: VALGANCICLOVIR HYDROCHLORIDE — Supplemental Application (NorthStar Rx LLC)
The FDA approved a supplemental application for valganciclovir hydrochloride by NorthStar Rx LLC, enabling a generic valganciclovir product.
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FDA approval · 2020-03-12FDA Approved: VALGANCICLOVIR — Supplemental Application (Camber Pharmaceuticals, Inc.)
FDA approved a supplemental application for a generic valganciclovir product, authorizing Camber Pharmaceuticals to market valganciclovir fo…
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FDA approval · 2020-01-31FDA Approved: VALGANCICLOVIR HYDROCHLORIDE — Original Application (Somerset Therapeutics, LLC)
FDA approved the original application for valganciclovir hydrochloride (generic valganciclovir) by Somerset Therapeutics, LLC.
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FDA approval · 2019-12-26FDA Approved: VALGANCICLOVIR — Original Application (Ajanta Pharma USA Inc.)
FDA approved the original ANDA for valganciclovir from Ajanta Pharma USA Inc., establishing a generic antiviral product. It is indicated for…
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FDA approval · 2018-11-08FDA Approved: GANCICLOVIR — Original Application (Slate Run Pharmaceuticals, LLC)
FDA approved the original application for a generic version of ganciclovir (ganciclovir sodium) from Slate Run Pharmaceuticals, LLC.
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FDA approval · 2018-08-02FDA 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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FDA approval · 2018-08-02FDA Approved: VALCYTE — Supplemental Application (H2-Pharma, LLC)
FDA approved a supplemental application for VALCYTE (valganciclovir) submitted by H2-Pharma, LLC.
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CLINICAL_TRIALS trial_result · 2018-07-26Clinical Trial Update: High-dose Intravitreal Injection of Ganciclovir for the Treatment of CMVR in HIV-negative Patients [NA]
Completion of a clinical trial evaluating high-dose intravitreal ganciclovir for cytomegalovirus retinitis in HIV-negative patients is repor…