Abbreviated New Drug Application
/ˈæbrɪˌviːeɪtɪd nuː drʌg ˌæplɪˈkeɪʃən/
Definitions
- (n.) A submission to the FDA requesting approval to market a new drug on the basis of demonstrating bioequivalence to an already approved drug, allowing expedited review.
The pharmaceutical company filed an Abbreviated New Drug Application to bring its generic drug to market more quickly.
Forms
- abbreviated new drug application
- abbreviated new drug applications
Related terms
See also
Commentary
Use the term specifically in regulatory contexts involving generic drug approval to distinguish it from a full New Drug Application; emphasize its reliance on bioequivalence data rather than clinical trials.
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