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The off-label uses of a drug may become additional on-label uses if the company submits a Supplemental New Drug Application and the FDA approves the application. SNDAs may take years to process and can be expensive. When a drug is off-patent or if the off-label use is for only a small population, there is little incentive (except that it is easier to advertise on-label uses) for a firm to obtain an SNDA.
Publication Source: Committees on Human Research
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