Alembic Pharmaceuticals Limited has received final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Valganciclovir for Oral Solution, 50 mg/m. The approved product is therapeutically equivalent to the reference listed drug (RLD), Valcyte, marketed by CHEPLAPHARM. The approval allows Alembic to market the generic formulation in the United States, subject to applicable regulatory and commercial requirements.
Valganciclovir is an antiviral medicine used in the treatment and prevention of cytomegalovirus (CMV) infections. The approved oral solution is indicated for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS). It is also indicated for the prevention of CMV disease in high-risk patients who have received kidney, heart or kidney-pancreas transplants. CMV infection can pose significant risks to people with weakened immune systems, including transplant recipients who receive medicines to prevent organ rejection.
The 50 mg/mL oral solution provides a liquid dosage option for patients who may require an alternative to tablet formulations. The USFDA’s final approval confirms that the generic product has met the regulatory requirements applicable to the ANDA pathway, including the demonstration of therapeutic equivalence to the reference product.
The approval adds another product to Alembic’s portfolio of generic medicines for the US market. The company develops, manufactures and markets pharmaceutical formulations and active pharmaceutical ingredients across several therapeutic areas. Its operations include research and development, manufacturing and regulatory capabilities supporting domestic and international markets.
The US remains an important market for Indian generic drug manufacturers, with regulatory approvals providing access to a range of treatment categories. Generic medicines are developed to offer alternatives to reference products after the applicable patent and regulatory requirements have been addressed.
Alembic Pharmaceuticals has a presence in branded formulations, generic products and active pharmaceutical ingredients. The company operates manufacturing facilities and research centres in India and supplies pharmaceutical products to markets across the world. The final USFDA approval for Valganciclovir Oral Solution 50 mg/mL expands the company’s approved product portfolio in the United States and adds a formulation for patients requiring treatment or preventive care for CMV-related conditions.
