FDA was again in the news just prior to closing down for holidays. The three items addressed by the regulating agency includes its reservations in approving major depressive disorder drug Seroquel XR from AstraZeneca. According to the company, however, this drug is their blockbuster and a version of release that is extended and has been approved for conditions like schizophrenia and bipolar disorder.
Approval of the newest indication is pending following the issuance of a complete response letter by the agency demanding more details before a final decision is made. The year 2011 will see the original Seroquel version losing its patent protection.
2011 will also see Actos, the diabetic pill from Takeda losing its patent protection. Actos is working towards developing and introducing another diabetic pill by then. This pill is alogliptin, which is similar to Januvia from Merck. Decision and approval on alogliptin by the FDA is pending from the month of October. Having missed this deadline, the agency has informed Takeda that a final decision will have to wait till next year June 26, according to Takeda.
In a letter posted on its website, FDA says advertisement for the drug Humira from Abbott is misleading as the indication approved is broadened and risk factor minimized significantly. FDA says the ad sounds as if the drug is useful for a wide range of psoriasis patients whereas in actuality it is not. Warning regarding the risk factors associated with the drug has been minimized to very small font size making it difficult to comprehend and read by users.
