#114049
#114050
Re: Farmas USA
Amarin files U.S. application for expanded label for Vascepa
Mar. 28, 2019 5:03 PM • SA Editor Douglas W. House
- Amarin (NASDAQ: AMRN) has filed a supplemental marketing application with the FDA seeking a cardiovascular (CV) benefit claim for Vascepa (icosapent ethyl) based on the results from the large-scale REDUCE-IT trial.
- Assuming the standard 10-month review cycle, the agency's action date (provided that it accepts the application in a timely manner) should be in Q1 2020.
#114051
Re: Farmas USA
#114052
Re: Farmas USA
#114053
Re: Farmas USA
#114054
Re: Farmas USA
#114055
Re: Farmas USA
#114056
