Pharmaceutical Business review

AstraZeneca submits new version of Seroquel for approval

The new version of Seroquel is a sustained release formula aimed at giving a therapeutically effective dose by the second day of treatment.

The submission will cover all markets in the EU where Seroquel is currently approved. This follows the new drug application for Seroquel submitted in the US earlier this year.

The sustained release formulation has patent protection to 2017. However, the original formulation of Seroquel is currently facing generic competition from Teva Pharmaceuticals. AstraZenca filed a lawsuit against the generic drug maker last year.

Seroquel has been licensed for the treatment of schizophrenia since 1997 and is the number one prescribed atypical antipsychotic in the US, with global sales of almost $2.8 billion in 2005.