FDA Approves Seroquel
FDA Clears Zeneca's Seroquel for the Management of the Manifestations of Psychotic Disorders, Including Schizophrenia
WILMINGTON, Del.--(BUSINESS WIRE)--September 29, 1997--Zeneca Pharmaceuticals today announced that the Food and Drug Administration (FDA) has cleared for marketing Seroquel (quetiapine fumarate) tablets, an oral medication indicated for the management of the manifestations of psychotic disorders, including schizophrenia. Seroquel is a new "atypical" antipsychotic agent in a new chemical class called dibenzothiazepine derivatives. The compound was discovered and developed by Zeneca Pharmaceuticals in its US research laboratories in Wilmington, Del.
"For more than 30 years, Zeneca Pharmaceuticals has made a significant commitment to discovery of compounds to treat central nervous system (CNS) disorders," said Robert C. Black, President of Zeneca Pharmaceuticals. "Seroquel represents our first entry into the antipsychotic market. We anticipate that the drug will provide Zeneca with a strong foundation for continued long-term success in the CNS market."
The portfolio of CNS products developed by Zeneca worldwide includes treatments for the management of migraine, epilepsy, anesthesia, anxiety and depression. Approximately 21 percent of the company's R&D expenditure is dedicated to the CNS area.
On August 4, 1997, Zeneca announced that it had received approval from the UK Medicines Control Agency to market Seroquel. The company is also pursuing approvals to market the product in other countries.
Seroquel is manufactured in the US and will be available by prescription throughout the US beginning in autumn 1997 in strengths of 25 mg, 100 mg, and 200 mg tablets. In clinical trials, efficacy was demonstrated in a dose range of 150 mg/day to 750 mg/day. A maximum therapeutic effect was seen at 300 mg/day in a dosing trial. In other studies, doses in the range of 400-500 mg/per day were effective. A dosing regimen of two to three times a day is recommended.
Zeneca Pharmaceuticals is a business unit of Zeneca Inc., a $3.1 billion bioscience business with approximately 7,200 employees in the US. Zeneca Inc. is a wholly-owned subsidiary of the UK-based Zeneca Group PLC (NYSE:ZEN), a major $9 billion international bioscience business engaged in the research, development, manufacture and marketing of ethical (prescription) pharmaceuticals, agricultural and specialty chemical products, and the supply of health care services.
CONTACT: Rachel Bloom Judith Auchard
Zeneca Pharmaceuticals Zeneca Inc.
Posted: September 1997
- FDA Approves AstraZeneca's Seroquel for Maintenance Treatment in Bipolar Disorder - May 14, 2008
- FDA Approves AstraZeneca's Seroquel For Bipolar Depression Treatment - October 23, 2006
- AstraZeneca Receives FDA Approval for Seroquel for Treatment of Mania Associated with Bipolar Disorder - January 13, 2004