ST LOUIS (MD Consult) - On December 4, 2009, AstraZeneca announced that the US Food and Drug Administration (FDA) has granted additional approvals for 2 of their Seroquel products: Seroquel and Seroquel XR (quetiapine fumarate). Both medications are considered atypical antipsychotic agents and have been previously approved for a number of mental health indications.
This new approval allows for the use of once-daily Seroquel XR as adjunctive treatment to antidepressants in adults with major depressive disorder. Seroquel XR has been previously approved for the acute and maintenance treatment of patients with bipolar disorder and schizophrenia.
The new approval of Seroquel allows for its use as treatment for schizophrenia in adolescents (aged 13 to 17 years) as monotherapy, and for the acute treatment of manic episodes associated with bipolar I disorder in children and adolescents (aged 10 to 17 years), both as monotherapy and as an adjunct to lithium or divalproex. The Seroquel pediatric approval was granted on the basis of data from 4 studies. Doses of 400 to 800 mg of Seroquel were specifically studied in the pediatric program.
圣路易斯(MD Consult)——2009年12月4日，阿斯利康公司宣布，美国食品药品管理局(FDA)正式批准扩大其两种Seroquel产品Seroquel和Seroquel XR(富马酸喹硫平)的适应证。这两种产品均属于非典型抗精神病药物，之前已获准用于多种精神疾病的治疗。
这一新的批准令准许Seroquel XR每日1次用于成年抑郁症患者抗抑郁药的辅助治疗。Seroquel XR之前已获准用于双相情感障碍和精神分裂症患者的急性期和维持期治疗。
这次还批准Seroquel作为精神分裂症青少年(年龄13~17岁)患者的单药治疗，以及作为Ⅰ型双相情感障碍相关躁狂发作儿童和青少年(年龄10~17岁)患者的急性期治疗，既可作为单药治疗，也可作为锂盐(lithium)或双丙戊酸(divalproex)的辅助治疗。FDA基于4项试验的数据批准了Seroquel用于儿科患者。儿科试验项目中具体评价的Seroquel剂量是400~800 mg。
