AstraZeneca has gained FDA approval for its Seroquel XR (quetiapine fumarate) tablets ? a sustained-release medicine for the treatment of schizophrenia in adult patients.
AstraZeneca has gained FDA approval for its Seroquel XR (quetiapine fumarate) tablets — a sustained-release medicine for the treatment of schizophrenia in adult patients. The drug development programme was based on the needs of patients and physicians for a wider choice of medicines that offer convenient once-daily dosing. With Seroquel XR patients can achieve a dose within the recommended range as early as the second day of treatment.
The agency's approval was based on a clinical trial of the drug at doses of 400 mg, 600 mg and 800 mg/day. The clinical trial was a placebo-controlled study of inpatients and outpatients (n=573) experiencing an acute exacerbation of symptoms of schizophrenia. Seroquel XR is to be launched in the second half of the year, and its US patent will expire in 2017.
The company is also studying Seroquel's use in adolescent mental illness, and plans to seek approval for generalized anxiety and major depressive disorder in 2009.