VALGANCICLOVIR HYDROCHLORIDE · HETERO LABS LTD V
Valganciclovir is a deoxynucleoside analogue cytomegalovirus (CMV) DNA polymerase inhibitor indicated for: Adult Patients Treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS). Prevention of CMV disease in kidney, heart, and kidney-pancreas transplant patients at high risk. Pediatric Patients Prevention of CMV disease in kidney and heart transplant patients at high risk. Studies ] . Studies ] .
Details
- Status
- Prescription
- First Approved
- 2001-03-29
- Routes
- ORAL
- Dosage Forms
- TABLET, FOR SOLUTION
Companies
VALGANCICLOVIR HYDROCHLORIDE Approval History
What VALGANCICLOVIR HYDROCHLORIDE Treats
3 indicationsVALGANCICLOVIR HYDROCHLORIDE is approved for 3 conditions since its original approval in 2014. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Cytomegalovirus Retinitis
- Acquired Immunodeficiency Syndrome
- Cytomegalovirus Disease
Same approved indications as VALCYTE (same active ingredient).
VALGANCICLOVIR HYDROCHLORIDE Boxed Warning
HEMATOLOGIC TOXICITY, IMPAIRMENT OF FERTILITY, FETAL TOXICITY, MUTAGENESIS AND CARCINOGENESIS Hematologic Toxicity: Severe leukopenia, neutropenia, anemia, thrombocytopenia, pancytopenia, and bone marrow failure including aplastic anemia have been reported in patients treated with valganciclovir [see Warnings and Precautions ( 5.1 )]. Impairment of Fertility: Based on animal data and limited human data, valganciclovir may cause temporary or permanent inhibition of spermatogenesis in males and su...
WARNING: HEMATOLOGIC TOXICITY, IMPAIRMENT OF FERTILITY, FETAL TOXICITY, MUTAGENESIS AND CARCINOGENESIS Hematologic Toxicity: Severe leukopenia, neutropenia, anemia, thrombocytopenia, pancytopenia, and bone marrow failure including aplastic anemia have been reported in patients treated with valganciclovir [see Warnings and Precautions ( 5.1 )]. Impairment of Fertility: Based on animal data and limited human data, valganciclovir may cause temporary or permanent inhibition of spermatogenesis in males and suppression of fertility in females [see Warnings and Precautions ( 5.3 )]. Fetal Toxicity: Based on animal data, valganciclovir has the potential to cause birth defects in humans [see Warnings and Precautions ( 5.4 )]. Mutagenesis and Carcinogenesis: Based on animal data, valganciclovir has the potential to cause cancers in humans [see Warnings and Precautions ( 5.5 )]. WARNING: HEMATOLOGIC TOXICITY, IMPAIRMENT OF FERTILITY, FETAL TOXICITY, MUTAGENESIS AND CARCINOGENESIS See full prescribing information for complete boxed warning. Hematologic Toxicity: Severe leukopenia, neutropenia, anemia, thrombocytopenia, pancytopenia, and bone marrow failure including aplastic anemia have been reported in patients treated with valganciclovir. ( 5.1 ) Impairment of Fertility: Based on animal data and limited human data, valganciclovir may cause temporary or permanent inhibition of spermatogenesis in males and suppression of fertility in females. ( 5.3 ) Fetal Toxicity: Based on animal data, valganciclovir has the potential to cause birth defects in humans. ( 5.4 ) Mutagenesis and Carcinogenesis: Based on animal data, valganciclovir has the potential to cause cancers in humans. ( 5.5 )
Clinical Trial Registry
3 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03586284 STACCATO results posted | 18-24396 | Ph 2, Ph 3 | terminated | Systemic and Topical Antivirals for Control of Cytomegalovirus Anterior Uveitis: Treatment Outcomes |
| NCT02297854 | 569-10 | Ph 1 | completed | Bioavailability Study of Valganciclovir Hydrochloride Tablets 450 mg Under Fasting Condition |
| NCT02296723 | 570-10 | Ph 1 | completed | Bioavailability Study of Valganciclovir Hydrochloride Tablets 450 mg Under Fed Condition |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
VALGANCICLOVIR HYDROCHLORIDE FDA Label Details
Indications & Usage
Valganciclovir is a deoxynucleoside analogue cytomegalovirus (CMV) DNA polymerase inhibitor indicated for: Adult Patients Treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS). Prevention of CMV disease in kidney, heart, and kidney-pancreas transplant patients at high risk. Pediatric Patients Prevention of CMV disease in kidney and heart transplant patients at high risk. 1.1 Adult Patients Treatment of Cytomegalovirus (CMV) Retinitis: Valganciclovir tablets, USP are indicated for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome ...
WARNING: HEMATOLOGIC TOXICITY, IMPAIRMENT OF FERTILITY, FETAL TOXICITY, MUTAGENESIS AND CARCINOGENESIS Hematologic Toxicity: Severe leukopenia, neutropenia, anemia, thrombocytopenia, pancytopenia, and bone marrow failure including aplastic anemia have been reported in patients treated with valgancic...
Looking for the branded version?
VALCYTE
Full clinical data, patents, trials, and competitive landscape for valganciclovir hydrochloride.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.