Alembic Pharma Gets USFDA Final Approval for Valganciclovir Oral Solution

Alembic Pharmaceuticals Limited 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. This generic drug is therapeutically equivalent to CHEPLAPHARM Arzneimittel GmbH's Valcyte for Oral Solution 50 mg/mL. The oral solution is indicated for the treatment of CMV retinitis in AIDS patients and for the prevention of CMV disease in transplant patients. This approval marks Alembic's 227th final ANDA approval from the USFDA, contributing to its cumulative total of 247 ANDA approvals.