APP Pharmaceuticals receives FDA approval to advertise Ganciclovir for Injection.
According to IMS Wellness, sales of this product for 2009 in the United States were around $13.5 million. Ganciclovir for Injection can be an antiviral drug, which can be used in the treating Cytomegalovirus retinitis in immunocompromised patients, including sufferers with obtained immunodeficiency syndrome , as well as for the prevention of CMV disease in transplant recipients at risk for CMV disease. CMV disease is certainly a serious illness that can result in blindness, transplant graft reduction and potential lack of life.The results of the feasibility stage, which includes the first 30 individuals to get the ACP, will serve to further validate basic safety conclusions demonstrated through pre-clinical testing. These individuals will be adopted for 45 days following the process and evaluated for adverse occasions. The 45-day feasibility data will end up being reviewed by an independent data safety monitoring panel ahead of FDA review. Additional subjects will be signed up for the pivotal phase of the trial following the FDA has completed its review. Scientific data possess demonstrated that patients with a center arrhythmia, known as atrial fibrillation, face a five-fold higher incidence of stroke.