AstraZeneca asked for more Seroquel information

AstraZeneca has been asked to provide more information on its product Seroquel XR (quetiapine fumarate) for major depressive disorder and is evaluating the request, it said today.

The company, which announced last week it had entered an agreement with MAP Pharmaceuticals to commercialise a nebulised form of budesonide, said the Food and Drug Administration (FDA) has sent a complete response letter (CRL) relating to the supplemental new drug application.

AstraZeneca said it was currently considering the CRL contents and the labelling revisions to Seroquel XR, which was previously approved for the treatment and maintenance of schizophrenia in adults and the acute treatment of bipolar disorder.

The CRL does not affect these recommendations, AstraZeneca added.

It stated: “AstraZeneca will continue discussions with the FDA and will provide a response to the agency in due course.”

Meanwhile, earlier this month saw the FDA analyse various asthma medicines and state that Symbicort (budesonide/formoterol fumarate dihydrate) – another AstraZeneca product – had more benefits than risks for adolescents and adults with asthma.

Symbicort is a combination of the inhaled corticosteroid budesonide and rapid beta2-agonist formoterol.