A 505(b)(2) application is based on the reference to studies performed by the owner of the reference drug. Since Company A does not own the data from the reference drug you cannot use their approval as the basis of your application. Depending on the situation, e.g., violation of Company A exclusivity, you might be able to submit an application referencing the originator's approval.
------------------------------
Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States
------------------------------
Original Message:
Sent: 10-Aug-2022 12:37
From: Anonymous Member
Subject: 505(b)(2) Drug Approval and Exclusivity
This message was posted by a user wishing to remain anonymous
Hello, If company A gets drug #1 approved under a 505(b)(2) and is granted exclusivity, can company B submit a 505(b)(2) for drug #2 based on drug #1's approval, even if drug #1 is still under FDA exclusivity?
Thank you kindly