The oral form is supposed to be the originally approved dosage form with all the approved efficacy and safety data. So when your new proposal to change from the originally approved oral dosage form to IM form, then one can rely on the previously established and approved dosage form data to support the 505(b)(2) NDA for the newly proposed IM dosage form. Hope this is clear!
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GRSAOnline
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Original Message:
Sent: 21-Aug-2017 09:28
From: Aria Mijin Kim
Subject: 505(b)(2) NDA
Hello,
My name is Mijin Kim working at a medical device manufacturing company and I have a question regarding 505(b)(2) application.
As far as I know, the purpose of 505(b)(2) is to allow companies to develop alternative therapies more quickly by relying on existing data. However, according to the following sentence (extracted from Fundamentals of US Regulatory Affairs), the applicant can rely on the data established for the drug's oral formulation, not an intramuscular injection. I think the red font below should be changed to 'an intramuscular injection'...could you help me to understand this concept?
For, example, a 505(b)(2) application can be submitted if the applicant has changed a product's route of administration from an oral form to an intramuscular injection. In this instance, the applicant can rely on the efficacy data and some of the safety data established for the drug's oral formulation already approved by FDA but will have to conduct studies showing safety and efficacy that relate to the change to the intramuscular dosage form. In addition, the applicant will have to establish a bridge (e.g., via comparative bioavailability data) between the proposed drug and the approved listed drug to demonstrate that reliance on FDA's previous findings of safety and effectiveness is scientifically justified.
Best regards
Mijin