Zeneca's Seroquel Gains UK Approval, Its First

Zeneca Pharmaceuticals has received marketing clearance, its first,from the UK's Medicines Control Agency for Seroquel (quetiapine), its treatment for schizophrenia. Seroquel represents Zeneca's first entry into the antipsychotic market.

The company has also received an "approvable" letter from the US Food and Drug Administration. Zeneca adds that it will work with the agency to "finalize labeling as quickly as possible." Final approval is expected in the third quarter, according to a company spokesperson.

Seroquel belongs to the atypical class of antipsychotics and has a similar pharmacological profile to Novartis' Clozaril (clozapine). It is active at multiple brain receptors, with a greater affinity for 5-HT2A receptors and a somewhat lower affinity for dopamine D1 and D2 receptors. It also has affinity for 5-HT1A and alpha1 and alpha2 adrenergic receptors as well as histamine H1 receptors.