Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Valganciclovir for Oral Solution, 50 mg/mL. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Valcyte for Oral Solution 50 mg/mL of CHEPLAPHARM Arzneimittel GmbH (CHEPLAPHARM).

Valganciclovir for oral solution is indicated for: treatment of cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS), and prevention of CMV disease in kidney, heart, or kidney-pancreas transplant patients at high risk. Refer label for a detailed indication and usage.

Alembic has a cumulative total of 247 ANDA approvals (227 final approvals and 20 tentative approvals) from the USFDA.