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

UsernamePublicRestriction
UsernamePublicRestriction

Seroquel XR Might Get Second Line For Depression, Anxiety Despite Safety Worry

Executive Summary

A second-line indication for AstraZeneca's Seroquel XR (quetiapine) in major depressive disorder and generalized anxiety disorder remains possible following a unanimous FDA advisory committee vote that the drug is not "acceptably safe" for the monotherapy claims in MDD and GAD that AstraZeneca had been seeking

You may also be interested in...



Regulatory Updates, In Brief

FDA won't review Merck Serono's oral cladribine NDA: FDA refused to file the NDA for Merck Serono's oral multiple sclerosis drug cladribine, the firm announced Nov. 30. The application was filed in September by the company's U.S. subsidiary EMD Serono (1"The Pink Sheet" DAILY, Sept. 30, 2009). FDA granted the cladribine NDA fast track status based on the need for an oral therapy in the subset of MS patients with relapsing disease. Though Merck Serono was first to submit an NDA for an oral therapy for relapsing MS, it has not been the odds-on favorite for first approval (2IN VIVO, November 2009). At Windhover's FDA/CMS Summit Dec. 3, FDA Office of New Drugs Director John Jenkins spoke generally of the agency's refuse-to-file actions, noting that if industry wants FDA to meet PDUFA review dates, complete applications must be submitted (3The IN VIVO Blog, Dec. 3, 2009)

Regulatory Updates, In Brief

FDA won't review Merck Serono's oral cladribine NDA: FDA refused to file the NDA for Merck Serono's oral multiple sclerosis drug cladribine, the firm announced Nov. 30. The application was filed in September by the company's U.S. subsidiary EMD Serono (1"The Pink Sheet" DAILY, Sept. 30, 2009). FDA granted the cladribine NDA fast track status based on the need for an oral therapy in the subset of MS patients with relapsing disease. Though Merck Serono was first to submit an NDA for an oral therapy for relapsing MS, it has not been the odds-on favorite for first approval (2IN VIVO, November 2009). At Windhover's FDA/CMS Summit Dec. 3, FDA Office of New Drugs Director John Jenkins spoke generally of the agency's refuse-to-file actions, noting that if industry wants FDA to meet PDUFA review dates, complete applications must be submitted (3The IN VIVO Blog, Dec. 3, 2009)

AstraZeneca Will Collect Longer-Term Safety Data For Seroquel XR

AstraZeneca is committed to new studies and could modify ongoing observational studies to collect data on the long-term safety issues that troubled an FDA advisory panel during its consideration of Seroquel XR (quetiapine) for treating major depressive disorder and generalized anxiety disorder

Related Content

Topics

UsernamePublicRestriction

Register

OM006665

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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

Cancel