On January 11, 2018, we went out on a limb prognosticating that the very low numbers of ANDA approvals in January might be linked to a new USP requirement on documentation of elemental impurities that went into effect January 1st (see post here). Since that time, the number of approvals has jumped from 2 to 4 (as posted on the FDA All Approvals site [here] through January 16th) but, considering we are more than halfway through January, that number is exceptionally low.
We did, however, obtain some interesting comments from other firms that appear to confirm our suspicions. Even with the word out through our post, and certainly through letters from FDA to specific applications, we are hearing that firms are hesitant to take a proactive approach to providing the required documentation for fear that their submission will be deemed an unsolicited amendment and will change the GDUFA review clock. Some feel it may be better to wait for an information request or discipline review letter before providing the information.
Without public word from OGD on how they want firms to handle this, it may take a few months before the approvals start flowing, if it is the elemental impurities data that is the hold-up. What’s a mother to do? I suggest if your ANDA happens to be lacking this required USP elemental elements documentation, call your project manager and ask how they want you to handle the submission.