The Office of Generic Drugs (OGD) issued MaPP 5200.7 (here) today that addresses the need for filing review for certain amendments and supplements to ANDAs. We all know that an Original ANDA must go through the filing review to determine if the ANDA is substantially complete to permit a substantive scientific review. But did you know that the same filing team at OGD also reviews certain amendments and supplements to determine if they can be received?
Well, if you are on the end of a Refuse-to-Receive (RTR) letter for one of these missives, you sure do. But don’t be surprised if one is on the way, if your amendment or supplement is for one of the following changes to the product:
- new strength of a solid oral dosage-form drug product
- change in concentration for a parenteral dosage-form drug product
- change in vial size, fill volume, and/or package size to a parenteral dosage-form drug product (i.e., total drug content)
- change in concentration of an oral liquid, ophthalmic, otic, transdermal, or topical drug product
- change in the formulation for any dosage form
Many of these changes may occur because you are adding an existing strength of a product to your ANDA, adding a newly approved strength of a reference listed drug product, adding a strength that is subject to an approved ANDA suitability petition, etc. However, it may be because, as in the case of a formulation change, that a new patent certification may be required, or that new strength exclusivity or patents must be addressed.
MaPPs define internally how FDA goes about its business. The publication of a MaPP is more for transparency purposes to let stakeholders better understand how FDA does its job. Hopefully, your submissions will be complete and you won’t receive an RTR for a supplement or amendment (interestingly enough, there is no regulatory basis to RTR an amendment, but that never really stopped FDA. It actually will benefit industry if OGD stops an incomplete amendment at the door, so you or OGD does not waste its time). I guess the Agency’s creative interpretation of an amendment as an “application,” which is usually referred to as an original application or supplement in the regulations and statute, does actually provide some order and benefit to both FDA and industry.