#1: NEW CHEMICAL ENTITY (NCE) MEANS A DRUG THAT CONTAINS NO ACTIVE MOIETY THAT HAS BEEN APPROVED BY FDA IN ANY OTHER APPLICATION SUBMITTED UNDER SECTION 505(b) OF THE ACT.
Per the FDA:
#2: ACTIVE MOIETY MEANS THE MOLECULE OR ION ------ EXCLUDING THOSE APPENDED ORTIONS OF THE MOLECULE THAT CAUSE THE DRUG BE AN ESTER, SALT (INCLUDING A SALT WITH HYDROGEN OR COORDINATION BONDS), OR OTHER NON-COVALENT DERIVATIVE (SUCH AS A COMPLEX, CHELATE, OR CLATHRATE) OF THE MOLECULE ----- RESPONSIBLE FOR THE PHYSIOLOGICAL OR PHARMACOLOGICAL ACTION OF THE DRUG SUBSTANCE.
A lot of people reasoned like this (& to me, it's an erroneous reasoning): They pointed to the first part of the FDA definition, above here --- ONLY THE FIRST PART ABOVE HERE, just #1 --- and say......
"In GSK's Lovaza, the EPA is an ACTIVE MOIETY in the drug .... and since AMRN's Vascepa also contains EPA.... Vascepa is NOT an NCE."
MY ARGUMENT is as follows:
#1 (in its entirety) + #2 (in its entirety) = NCE for Vascepa for AMRN.
Why or how?
"MOIETY" (what is RESPONSIBLE for the action of the DRUG) does not mean JUST ONE PART or one molecule or ion (if the drug has 2 or more molecule compounds, or ions, in it as ACTIVE ingredients ("active ingredients" means being an INTEGRAL PART of the "physiology or pharmacology action of the drug substance") .......... INSTEAD ..... it means ALL OF THE ACTIVE INGREDIENTS in the drug.
Put another way:
The drug action (or the chemistry) of SODIUM CHLORIDE is different from the drug action (chemistry) of POTASSIUM CHLORIDE and the latter's drug action (chemistry) is different from CHLORINE's drug action (chemistry).
JUST because you have CHLORINE (a chemical) in all of these THREE molecular compounds DOES NOT mean their "MOIETY" --- or their physiological or pharmacological action of the drug substance --- is the same. THEY ARE NOT THE SAME.
Of course, THIS is only an ANALOGY on chemical analogies.... But in point of fact, on their own merits (in terms of how they affect our body), we know POTASSIUM CHLORIDE is healthier than SODIUM CHLORIDE. Chlorine, of course, is not so good for your body....
The message on ihub I just posted talks about isomers and the fdara which adds the addendum to the hicks-wax man law accepting individual isomers as NCE even if racemic EPA has been previously approved. You are talking about individual elements. Don't post on things you don't understand.
Since I don't know the future, I should defend CHLORINE:
There may come a time in some distant future, that Chlorine may be found to be good, as a drug, for some very specific deleterious mutational effect in the body, when applied carefully and appropriately....
Shouldn't CHLORINE, or POTASSIUM or SODIUM.... in that future time .... be granted an NCE status for that specific deleterious genetic condition or not?
Of course, it should.... if a scientist/researcher is intelligent enough to have found, in such a time --- via careful human clinicology --- that CHLORINE, or POTASSIUM, or SODIUM.... is efficacious for that medical condition (whatever it may be, if it should come into existence)...