It may not be considered 'novel' if it is already used in another approved product by a different route of administration. However, it will have a 'novel' use (route) and you will need safety information to support its use by the new route of administration. This could raise all kinds of potential safety issues and questions. some or al of the original safety information may be very applicable to the new route.
The FDA has 'inactive ingredients database' on the webpage. It lists all excipients that have been used in approved products, the route and maximum concentration used. Any other use or amount would requirement appropriate data to support.
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Michael Hamrell, Ph.D., RAC, FRAPS
Nipomo CA
United States
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Original Message:
Sent: 08-Sep-2022 16:15
From: Anonymous Member
Subject: Novel Excipients
This message was posted by a user wishing to remain anonymous
505(b)(2) Novel excipients section
Are excipients still considered "novel" if it is already approved in other modes of administration (i.e. oral) but not in the mode of administration that the 505 is demonstrating? (i.e. injection) We have done studies to support the safety of the injection which is contained in Module 4 and supported by a FDA premeeting.