The U.S. Food and Drug Administration (FDA) on Wednesday announced that it has approved generic versions of the atypical antipsychotic medication, Seroquel (quetiapine). Seroquel is commonly prescribed to treat symptoms of both schizophrenia and bipolar disorder.
Seroquel was initially approved to treat schizophrenia by the FDA in 1997. It received approval from the FDA to treat symptoms associated with bipolar disorder in 2004.
While quetiapine is not approved by the FDA for the treatment of behavioral problems in older adults with dementia, it is nonetheless commonly prescribed to older adults for a variety of concerns.
Quetiapine is one of many popular drugs recently approved by the FDA in a generic form. Generic drugs provide safe and effective alternatives to brand name drugs, usually at a lower cost.
Schizophrenia is a chronic, severe, and disabling mental disorder. The problem affects around one percent of Americans, according to the National Institute of Mental Health (NIMH). People with schizophrenia may hear voices other people don’t hear. They may believe other people are reading their minds, controlling their thoughts, or plotting to harm them.
Schizophrenia affects both men and women equally. It usually begins in the teen years or young adulthood but may begin later in life.
While treatment helps relieve many symptoms of both schizophrenia and bipolar disorder, most people who have these disorders cope with symptoms throughout their lives.
Seroquel helps decrease hallucinations, improves concentration, and prevents or decreases severe mood swings. The exact mechanisms of why Seroquel works are unknown.
In addition to treating schizophrenia, quetiapine is used alone or with other medications to treat or prevent episodes of mania or depression in patients with bipolar disorder. Quetiapine may be used as part of a treatment program to treat bipolar disorder and schizophrenia in children.
The FDA expects that quetiapine tablets will be manufactured in several different strengths — likely in 25, 50, 100, 200, 300, and 400 mg tablets — and will be available to the public within the next 6 months.
The new announcement does not apply to sustained-release versions of the drug, which was approved in 2006 and will continue to remain available only as a brand name prescription.