Just need to clear the air here, what was this Lovaza sNDA specifically for?
from the FDA website glossary:
"A supplement number is associated with an existing FDA New Drug Application (NDA) number. Companies are allowed to make changes to drugs or their labels after they have been approved. To change a label, market a new dosage or strength of a drug, or change the way it manufactures a drug, a company must submit a supplemental new drug application (sNDA). Each sNDA is assigned a number which is usually, but not always, sequential, starting with 001."
So first and foremost, what specifically is the change to Lovaza's label? And if you'd like to elaborate on what this has to do with vascepa/amarin, I would greatly appreciate it. Sorry if i'm just "not getting it". Greatly appreciate your research, just need help connecting dots and getting clarity on what it means.