logo
Share SHARE
FONT-SIZE Plus   Neg

FDA Replies To AstraZeneca Citizen Petitions On Quetiapine Product Labeling

AstraZeneca Plc (AZN,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.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Hard Rock Hotel & Casino Las Vegas, owned by Hard Rock Hotel Holdings, LLC, joins the long list of hotels whose payment-card data were hacked of late. Hard Rock on Monday said its investigation identified unauthorized access to the resort's customer payment-card data, after malware was placed on the payment-card system. The U.S. chain of theme restaurants, plans to open a high-end hotel in London. Gambling resorts operator Wynn Resorts Ltd. (WYNN), has again postponed the opening of its Wynn Palace casino resort in Macau to August. The opening of the $4 billion hotel project in Macau, the gambling hub in China, was initially planned on March 25, but was later dropped due to construction delays.... PepsiCo Inc., (PEP) Monday confirmed that it would bring back the Diet Pepsi with aspartame in the US stores in September, one of the latest efforts by the beverage giant to boost its slowing sales. The company said it would continue to sell sucralose-sweetened Diet Pepsi, which was launched last...
comments powered by Disqus
Follow RTT