For those who are not in the biz, it may surprise you to learn that the FDA does not decide what a drug is indicated for. It only decides if the indication that Pharma chooses to request is approved or not. If Risperdal is approved for bipolar mania but not maintenance, it doesn't mean that it isn't safe and efficacious for maintenance; or that there isn't a huge collection of data affirming this. It means Janssen didn't ask the FDA for the approval. In other words, 95% of the decision for an indication is made by the folks down at Pharma marketing. All the FDA can do is say yes or no.