“me-too” drug, (Informal) a drug product that is similar, identical, or closely related to a drug for which a manufacturer has obtained a new drug application. The drug is placed on the market by a company or companies other than the holder of the new drug application. On the assumption that the new drug has been recognized as safe and effective, clinical trials required of the original manufacturer are not required of the new supplier, but information regarding the manufacture, bioavailability, and labeling of the product is required to complete the abbreviated procedure for approval by the U.S. Food and Drug Administration.
