Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


Seroquel supplement for anxiety submitted

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

AstraZeneca's Seroquel XR would be the first atypical antipsychotic marketed for generalized anxiety disorder, if the sNDA submitted May 7 is approved. The GAD submission is part of AstraZeneca's larger attempts to expand Seroquel's label: additional submissions were made for major depressive disorder and bipolar mania and depression in January and February 2008. AstraZeneca is also considering Seroquel XR in pediatric patients and as an adjunct to serotonin and norepinephrine reuptake inhibitors and SSRIs. Seroquel XR loses exclusivity in 2010. Three short-term and one long-term placebo-controlled trials support the GAD sNDA; all met their primary endpoint





Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts