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A “me too” drug is a new chemical entity that is structurally similar to another drug product already on the market. Most drug products recently approved by the U.S. Food and Drug Administration (FDA) are me too drugs. The term me too today carries a negative connotation. It is believed that a focus of pharmaceutical research and development funds on creating molecularly similar compounds is wasteful and not clinically useful, but in a free-market economy, drug development will follow the best path to financial success.

The first antibiotic, Prontosil (a water-soluble red dye), was discovered by Gerhard Domagk at Bayer’s laboratory in the 1930s. It was soon discovered that it was not the dye that killed bacteria, but a part of the molecule itself that only ...

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