Federal Judge Prods FDA, Amarin To Agree On Off-Label Disclaimer Language

July 8, 2015 at 11:27 AM
NEW YORK -- U.S. District Court Judge Paul Engelmayer prodded Amarin Pharma, Inc. and FDA Tuesday (June 7) to come to terms on disclaimer language the pharmaceutical company can use if it wants to share information with doctors on off-label use of its Vascepa product, but the parties didn't budge as he heard oral arguments in Amarin’s request for a preliminary injunction shielding the company from criminal prosecution in its suit filed against the agency in May . The judge...


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