AstraZeneca Wants Expanded Use for Seroquel
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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 have the drug prescribed to patients suffering from depression. Seroquel XR, is currently approved in the U.S. only for the treatment of schizophrenia or bipolar disorder.
"AstraZeneca is evaluating the contents of the CRL and the proposed labeling revisions," the company said in a statement to the London Stock Exchange. "AstraZeneca will continue discussions with the FDA and will provide a response to the agency in due course."
Not that approval is always necessary before a drug is used.
In adolescents, the medications are given for depression, autism and hyperactivity, and in the elderly for dementia and insomnia. Half of Seroquel’s sales in 2006 were reportedly for off-label use.
Seroquel is AstraZeneca's second-best seller behind heartburn drug Nexium, It raked in $4 billion in sales last year.
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. And expect to see more side effects if the FDA approves the expanded use of this powerful drug.
AstraZeneca earlier this year won a key decision in a U.S. court that means that generic copies of the drug will not be launched any time soon.#