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I'm a tad embarrassed to have to ask this, but I was unable to find this out on my own - A drug that's approved for one indication and the manufacturer wants to have it approved for a new indication needs to get an NDA or an IND? I thought it was an NDA but I'm aware of a major drug that is undergoing IND approval by the FDA and it's already in use for another indication. Can someone 'splain me how this works? I need to interview an author soon about this. any help is appreciated. thanks jeanne %%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%