NCE
A drug containing an active ingredient never previously approved by the FDA.
Definition
A New Chemical Entity (NCE), aka New Molecular Entity (NME), is a drug containing an active moiety that has not been previously approved by the FDA. NCEs receive 5 years of regulatory exclusivity in the US (orphans get 7) — a barrier on top of any patent protection. CDER's annual report tracks NME approvals by therapeutic area.
See also
- NDA — New Drug Application — the FDA submission required to market a new small-molecule drug in the US.