AstraZeneca files NDA for once-daily Seroquel

AstraZeneca has petitioned the FDA to allow once-daily version of its second-best selling drug Seroquel, a treatment of acute manic episodes with bipolar disorder and schizophrenia. The drug, which was approved in 1997, did $2.76 billion in sales last year, up 35 percent from 2004. But despite the strong sales, the company is concerned that the older formula of Seroquel could face competition from Israel's generic drug maker Teva, which is planning to launch a copycat.

- see this press release