The US Food and Drug Administration (FDA) has granted final approval to a generic valganciclovir oral solution, 50 mg/mL, providing an additional treatment option for cytomegalovirus (CMV) infection prevention in high-risk transplant recipients and CMV retinitis treatment in patients with AIDS, Alembic Pharmaceuticals announced in a press release.
The approval covers an abbreviated new drug application (ANDA) for a product therapeutically equivalent to Valcyte for Oral Solution, 50 mg/mL, the reference-listed product held by CHEPLAPHARM Arzneimittel GmbH, according to a company announcement.
Valganciclovir is indicated for the treatment of CMV retinitis in adults with AIDS and prevention of CMV disease in high-risk kidney, heart, and kidney-pancreas transplant recipients. The reference product's labeling also includes CMV prophylaxis in pediatric kidney transplant recipients aged 4 months to 16 years and heart transplant recipients aged 1 month to 16 years. High-risk transplant recipients include those who are CMV-seronegative and receive organs from CMV-seropositive donors.
The approval was granted through the ANDA pathway, which establishes therapeutic equivalence to an approved reference product without requiring new pivotal efficacy trials. Alembic did not report new clinical efficacy or safety findings with the announcement.
Valganciclovir carries boxed warnings for hematologic toxicity, impairment of fertility, fetal toxicity, mutagenesis, and carcinogenesis. Clinically significant adverse effects include neutropenia, anemia, and thrombocytopenia. Prescribing information recommends monitoring blood counts and renal function, with dose adjustments required in patients with renal impairment.
The reference product's labeling specifies that adults should use valganciclovir tablets rather than the oral solution, unless they are unable to swallow tablets. The solution must be prepared by a pharmacist before dispensing and administered with food. Pediatric prophylaxis dosing is individualized according to body surface area and renal function.
Sources: Alembic Pharmaceuticals,DailyMed
