Ganciclovir for injection is an antiviral drug, which is used for the treatment of Cytomegalovirus (CMV) retinitis in immunocompromised patients, including patients with acquired immunodeficiency syndrome (AIDS), as well as for the prevention of CMV disease in transplant recipients at risk for CMV disease.
APP Pharma said that the drug is therapeutically equivalent to the reference-listed drug Cytovene-IV, which is marketed by Roche Laboratories.
APP Pharma is expecting to launch the Ganciclovir for injection soon in the market.
APP will package the product in single dose, 500 mg vials. It’s Ganciclovir for injection is AP-rated, latex-free and bar-coded.
John Ducker, president and CEO of APP Pharma, said: “This approval reinforces APP’s commitment to provide our customers, and the patients they treat, with a consistently expanding portfolio of products. The addition of Ganciclovir for injection further strengthens APP’s broad anti-infective portfolio.”