5/1/14 - NADA Submissions Part 1

Q – What is the latest information regarding New Animal Drug Application (NADA) submissions for drug listings?

A – The Center for Veterinary Medicine (CVM) has implemented additional validation procedures on medical gas drug listings for animal drugs. The agency believes that listings with NADA numbers should be classified as an Active Pharmaceutical Ingredient (API). We disagree with the Agency’s position and have formally notified the agency of our objections.

The API requirements cause significant disruptions in the listing process for animal drug gases. After resolving this issue with the FDA, we will let you know how to proceed.

Interestingly, this does not seem to affect the human drug listings. We recommend that you continue to re-list your medical gases with the NDA (for humans) number in order to remove the “unapproved medical gas” statement from your drug listings