FDA approves Aurobindo’s generic Valcyte

SILVER SPRING, Md. — Aurobindo Pharma on Wednesday received Food and Drug Administration for its generic Valcyte (valganciclovir) tablets. The drug is indicated to treat cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome, as well as to prevent CMV in high-risk kidney, heart, or kidney-pancreas transplant. 

 

The product has an estimated market size of $390.6 million for the 12 months ending February 2016 according to IMS Health. The drug will be available in 450-mg tablets.