A drug that is identical, similar, or closely related to a drug product for which a new drug application has been approved, Many ‘me too’ drugs on the market are essentially copies of approved new drug but were introduced by the manufacturers without Food and Drug Administration approval on the theory that the NDA holder, or pioneer drug, had become generally recognized as safe and effective. Other ‘me too’ products are being marketed with abbreviated new drug applications (ANDAs), which require the submission of manufacturing, bioavailability and labeling information, but not data relating to safety and effectiveness, which are assumed to be established.