Replies to post #9424 on Amarin Corp Plc (AMRN)

[BioChica]

Lovaza Phase 4 Trial. ClinicalTrials.gov Identifier:
NCT01301794
GSK trying to expand Lovaza use? in 150-500 Triglyceride Range.
This is a very small trial, what are they doing?

Trial completed by the end of the year.
Lovaza Mechanisms of Action
This study is currently recruiting participants.
Verified February 2013 by Brigham and Women's Hospital
Sponsor:
Brigham and Women's Hospital
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Jorge Plutzky, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01301794
First received: February 18, 2011
Last updated: February 21, 2013
Last verified: February 2013
Estimated Enrollment: 40
Study Start Date: August 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Ages Eligible for Study: 21 Years to 65 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: Yes
Criteria

Inclusion Criteria:

Otherwise healthy 21 to 65 year old men and women
Triglycerides >150 < 500 mg/dL

Exclusion Criteria:

Other lipid lowering medication including fish oil
Major illnesses
Diabetes
Cardiovascular disease
Abnormalities uncovered on screening blood work including undiagnosed diabetes, abnormal liver function tests, triglycerides > 500 mg/dL
Indication for immediate statin therapy
Pregnancy
Contraindication for fish oil use or muscle biopsy

[Laurent Maldague]

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.