New Chemical Entities

 Definition. A chemical entity is a physical entity of interest in chemistry including molecular entities, parts thereof, and chemical substances. New chemical entity. ... A new molecular entity (NME) is a drug that contains an active moiety that has never been approved by the FDA or marketed in the US. It's important to note the difference between an NCE and a New Molecular Entity (NME). While an NCE has no active moiety, an NME contains an active moiety that has not yet been approved by the FDA or marketed in the U.S. Preferred citation: These NCE-1 dates indicate the first opportunity for generic drug companies to file Abbreviated New Drug Applications (ANDAs) for generic entry into branded drug markets. Generic launch is dependent on many factors, including FDA approval and patents. Active moiety is the molecule or ion, excluding those appended portions of the molecule that cause the drug to be an ester, salt (including a salt with hydrogen or coordination bonds), or other noncovalent derivative (such as a complex, chelate, or clathrate) of the molecule, responsible for the physiologica. New chemical entity. A new chemical entity (NCE) is, according to the U.S. Food and Drug Administration, a drug that contains no active moiety that has been approved by the FDA in any other application submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act.