FDA Roundup: Drugs for Depression, Diabetes and Psoriasis

In spite of that big broken water main, the FDA managed to make a bit of news before everything shuts down for the holiday. Three key items:

1. The agency isn’t ready to approve AstraZeneca’s drug Seroquel XR for major depressive disorder, the company said. The drug — an extended release version of the company’s blockbuster — has already been approved for bipolar disorder and schizophrenia.

But the agency issued a complete response letter asking for more information before making a final decision on whether the drug should be approved for the newest indication. The original version of Seroquel is likely to lose patent protection in 2011.

2. Also likely to lose patent protection in 2011 is Takeda’s diabetes pill Actos. By that time, the company hopes to have another diabetes medicine on the market: alogliptin, in the same class as Merck’s Januvia. The FDA was supposed to issue a decision on alogliptin by October of this year, but missed the deadline. Now, the agency says it will make a decision by June 26 of next year, Takeda said today.

Read the full article at wsj.com