FDA draws line in sand over its orphan drug policies Agency will abide by court ruling in Depomed case, but that case only, it says in clarification January 9, 2015 | By Eric Palmer

The FDA says it will abide by a court ruling stating it has to grant orphan drug exclusivity to Depomed's ($DEPO) Gralise, even though it has vigorously fought doing so on the belief that it was essentially the same as one already approved, Pfizer's ($PFE) Neurontin, and so it is not entitled to the added benefits. But the agency has drawn a line in the sand, saying it does not intend to extend the same benefit to any other drugmakers under the same circumstances. more