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

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.