Important Change to NDA 021870

The Coalition would like to make PET drug manufacturers aware of a change to an FDA-approved application for Fludeoxyglucose F 18 Injection (FDG). This modification involves the radioactivity concentration (strength) for FDG described in new drug application (NDA) 021870, which is held by the Feinstein Institute for Medical Research. This change only applies to NDA 021870 and became effective on July 9, 2015. Specifically, the change was to increase the maximum radioactivity concentration from 300 mCi/mL to 400 mCi/mL.

While the modification may not seem significant at first glance, it raises the question of the potential impact on abbreviated new drug applications (ANDAs) that reference NDA 021870. To address this question, members of the PET community have contacted the FDA Office of Generic Drugs (OGD) for clarification. In response, OGD stated that it is not necessary to change the radioactivity concentration in ANDAs that reference NDA 021870. Consequently, no revisions to the product label are required for these ANDAs, nor is it necessary to perform new stability studies.

However, the change allows for an increase in the concentration of FDG up to 400 mCi/mL for ANDAs that reference NDA 021870. If an ANDA holder elects to change the concentration of the product described in their application, applicants are advised that changes to their specific product would require new stability studies, as well as an updated label that is revised as part of a prior approval supplement. In the communication from OGD, they noted that a suitability petition is not required to support a concentration up to 400mCi/mL.

Thanks to Dan Yokell at Massachusetts General Hospital and Bob Wolfangel at Certis International for bringing this information to the attention of the Coalition. The Coalition will share further information on this topic as necessary.

More information on NDA 021870 may be found on the FDA’s “Drugs@FDA” website at this URL.  In the search window, type 021870 to access the NDA.

More information on prior approval supplements may be found in the post entitled, “Sponsored Session from SNMMI Annual Meeting: Current Topics in FDA Reviews and Inspections of PET Drug Manufacturers,” that appeared on the Coalition’s website on June 25, 2015 (see below).

Questions? Please leave a comment in the comments section below.

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