AstraZeneca says the Food and Drug Administration (FDA) wants more information before it approves the schizophrenia drug Seroquel for expanded uses. The drug maker received a “complete response letter” from the FDA after it applied to be able to prescribe Seroquel for patients suffering from depression.
Seroquel XR, is currently approved in the U.S. only for the treatment of schizophrenia or bipolar disorder.
Not that approval is always necessary before a drug is used.
In adolescents, the medication is given for depression, autism and hyperactivity, and in the elderly for dementia and insomnia. In fact, check a loved one’s prescriptions if they are in a nursing home, especially if they have Alzheimer’s disease. It is very likely they are given Seroquel.
Half of Seroquel’s sales in 2006 were reportedly for off-label use.
In September 2003, the FDA recommended that six atypical antipsychotics, including Seroquel, carry a diabetes warning because Seroquel patients were three times more likely to develop diabetes than those taking older drugs.
The most common side effects of Seroquel use include, but may not be limited to, drowsiness, weight gain, restlessness, dizziness, increased appetite, constipation and fatigue.
Seroquel is AstraZeneca’s second-best seller behind heartburn drug Nexium, It raked in $4 billion in sales last year.
In October, Seroquel received FDA approval for its extended-release version to be used to treat bipolar disorder, making Seroquel XR (“XR” indicates extended release), the first medication cleared for depressive and manic episodes associated with bipolar disorder. It was approved as a once-daily treatment. The previous version was taken twice a day and not approved for mixed episodes.
Recreating the drug with an XR means that the patent is protected until 2017. The original formula was set to expire in 2011. Patients will be switched into the XR version.