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Aurobindo Receives FDA Approval for Valganciclovir for Oral Solution, 50mg/mL

Published: November 29, 2022

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Valganciclovir for Oral Solution, 50mg/mL. Aurobindo Pharma’s Valganciclovir for Oral Solution, are an AB-rated generic equivalent to the reference listed drug (RLD), VALCYTE® for oral solution 50mg/1mL, manufactured by HOFFMANN LA ROCHE INC .

Valganciclovir for Oral Solution are indicated for:

  • The prevention of Cytomegalovirus (CMV) disease in kidney and heart transplant patients at high risk.