Alembic Pharmaceuticals Limited 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:
1) Treatment of cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS)
2) Prevention of CMV disease in kidney, heart, or kidney-pancreas transplant patients at high risk
This approval brings Alembic's cumulative total of ANDA approvals from the USFDA to 247, comprising 227 final approvals and 20 tentative approvals.
The company is a vertically integrated research and development pharmaceutical company headquartered in India, manufacturing and marketing generic pharmaceutical products worldwide with state-of-the-art research and manufacturing facilities approved by regulatory authorities including USFDA.