Quick Facts
FONT-SIZE Plus   Neg
Share SHARE

FDA Replies To AstraZeneca Citizen Petitions On Quetiapine Product Labeling

AstraZeneca Plc (AZN: Quote,AZN.L) announced that on March 7, 2012, the Food and Drug Administration, or FDA, denied Citizen Petitions requesting that the FDA withhold finally approving any generic quetiapine product with labeling that omits certain hyperglycemia warning language that the FDA required AstraZeneca to include in the labeling for SEROQUEL (quetiapine fumarate) tablets and SEROQUEL XR (quetiapine fumarate) extended-release tablets.

The company stated that it is evaluating the FDA's decision and reasoning.

Click here to receive FREE breaking news email alerts for AstraZeneca PLC and others in your portfolio

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
U.K. mortgage approvals increased more-than-expected to a 4-month high in June, recovering from a temporary slowdown caused by mortgage lending regulations. After four months of decline, approvals for house purchases increased to 67,196 in June from 62,007 in May, the Bank of England data showed Tuesday. It was forecast to rise to 63,000. The latest figure was the highest since February. New Zealand's diary giant Fonterra lowered its forecast for farmer payouts for the 2014/15 season citing falling world dairy prices and a strong New Zealand dollar. The 2014/15 Farmgate Milk Price forecast was lowered to NZ$6 per kg of milk solids from its earlier estimate of NZ$7 per kg in May, the... Home improvement and building products company Masco Corp. said Monday after the markets closed that its second quarter profit jumped 78% from last year, as revenue increased and margins improved amid strong performance of its Plumbing Products, Installation and Other Services and Decorative Architectural Products segments.
comments powered by Disqus
FREE Newsletters, Analysis & Alerts

 

Stay informed with our FREE daily Newsletters and real-time breaking News Alerts. Sign up to receive the latest information on business news, health, technology, biotech, market analysis, currency trading and more.