valganciclovir hydrochloride
valganciclovir hydrochloride is listed in the FDA National Drug Code directory with 3 NDC codes, marketed under brand names including valganciclovir hydrochloride, Valcyte. Available dosage forms: for solution, powder, for solution, tablet.
Drug Details
- Generic Name
- valganciclovir hydrochloride
- Brand Names
- valganciclovir hydrochloride, Valcyte
- Application Number
- ANDA210169
- Sponsor
- Novadoz Pharmaceuticals LLC
- NDC Codes
- 3
- Dosage Forms
- FOR SOLUTION, POWDER, FOR SOLUTION, TABLET
- Routes
- ORAL
- Active Ingredients
- VALGANCICLOVIR HYDROCHLORIDE
Indications and Usage
1 INDICATIONS AND USAGE VALCYTE is a deoxynucleoside analogue cytomegalovirus (CMV) DNA polymerase inhibitor indicated for: Adult Patients ( 1.1 ) 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 ( 1.2 ) Prevention of CMV disease in kidney and heart transplant patients at high risk. 1.1 Adult Patients Treatment of Cytomegalovirus (CMV) Retinitis: VALCYTE is indicated for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS) [see Clinical Studies (14.1) ] . Prevention of CMV Disease: VALCYTE is indicated for the prevention of CMV disease in kidney, heart, and kidney-pancreas transplant patients at high risk (Donor CMV seropositive/Recipient CMV seronegative [D+/R-]) [see Clinical Studies (14.1) ] . 1.2 Pediatric Patients Prevention of CMV Disease: VALCYTE is indicated for the prevention of CMV disease in kidney transplant patients (4 months to 16 years of age) and heart transplant patients (1 month to 16 years of age) at high risk [see Clinical Studies (14.2) ] .