US FDA approves AstraZeneca's Seroquel XR for add-on treatment of MMD and standard drug for pediatric use

4 December 2009

The US Food and Drug Administration has approved Anglo-Swedish drug major AstraZeneca's once-daily blockbuster drug Seroquel XR (quetiapine fumarate) extended release tablets as adjunctive (add-on) treatment to antidepressants in adults with major depressive disorder (MDD).

The FDA also cleared standard Seroquel for the treatment of schizophrenia in adolescents (13-17 years of age) as monotherapy, and for the acute treatment of manic episodes associated with bipolar I disorder in children and adolescents (10-17 years of age), both as monotherapy and as an adjunct to lithium or divalproex.

Seroquel is a big money spinner for AstraZeneca, generating sales of $3.6 billion in the first nine months of the year, $2.5 billion of which came from the US market, up 16% on the previous year's three-quarter total. The news saw the UK-headquartered company's share price rise just over 0.9% to £27.97 on the London market where the FTSE 100 dipped 0.6% in morning trading.

This article is accessible to registered users, to continue reading please register for free.  A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Login to your account

Become a subscriber

 

£820

Or £77 per month

Subscribe Now
  • Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
  • Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
  • Daily roundup of key events in pharma and biotech.
  • Monthly in-depth briefings on Boardroom appointments and M&A news.
  • Choose from a cost-effective annual package or a flexible monthly subscription
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK



Company News Directory



Companies featured in this story

More ones to watch >


Today's issue

Company Spotlight





More Features in Pharmaceutical