A material or a composition that has not been previously used in an approved drug product in the US (i.e. not listed in FDA Inactive Ingredient Database (IID)) or that has been previously used in an approved drug product but which it is desired to employ for a new route of administration, or a higher level of use than has been previously listed in the IID, or a new co-processed excipient made from two or more previously approved excipient.
Glossary
Novel Excipient
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