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Re: Biobillionair post# 28781

Thursday, 06/05/2014 3:35:28 AM

Thursday, June 05, 2014 3:35:28 AM

Post# of 426271
BB,

What do you mean exactly?

The last changes were on 05/14/2014 and the deletion of 14.2 was discussed on this board.

Main changes:

(Deleted the bold part):
Limitations of Use:
• The effect of LOVAZA on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined. (1)
• The effect of LOVAZA on cardiovascular mortality and morbidity in patients with severe hypertriglyceridemia has not been determined. (1)

Deleted sections:
- 14.2 Other Clinical Experience
- 17.1 Information for Patients
- 17.2 FDA-Approved Patient Labeling
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