Skip to main content

FDA tentatively approves Seroquel generic


JERUSALEM The Food and Drug Administration has given tentative approval to a generic version of AstraZeneca's antipsychotic Seroquel.

Teva announced last Tuesday that the FDA had granted the tentative approval for generic Seroquel (quetiapine fumarate) in 25 mg, 50 mg, 100 mg, 150 mg, 200 mg, 300 mg and 400 mg strengths.

The branded version of the drug had sales of about $3.8 billion in the United States for the 12 months ending Sept. 30, according to IMS Health data.

Teva expects to receive final approval after resolving patent litigation with AstraZeneca.

This ad will auto-close in 10 seconds