ICOSAPENT ETHYL

FDA-2019-P-3424 · 3 docket documents

Medical Research Collaborative, LLC filed this citizen petition on July 16, 2019, requesting that the FDA delay approval of the supplemental New Drug Application (sNDA) for icosapent ethyl (Vascepa) until drug-drug interaction studies demonstrate that mineral oil in the placebo does not attenuate th

FDA-2019-P-3265 · 3 docket documents

Medical Research Collaborative, LLC filed this citizen petition on July 8, 2019, requesting that the FDA Commissioner remove Amarin Corp.'s U.S. Patent No. 8,188,146 from the Orange Book because the patent does not claim an approved method of using icosapent ethyl (Vascepa) for its FDA-approved indi

FDA-2019-P-3156 · 3 docket documents

Medical Research Collaborative, LLC filed this citizen petition under 21 C.F.R. § 10.30 and 10.31 requesting that the FDA Commissioner delay approval of the supplemental New Drug Application for icosapent ethyl (Vascepa) until drug-drug interaction studies demonstrate that mineral oil in the REDUCE-

FDA-2014-P-0878 · 3 docket documents

Amarin Pharma Inc. filed this citizen petition on June 24, 2014, requesting that the FDA impose specific bioequivalence testing requirements on any abbreviated new drug application (ANDA) listing Vascepa (icosapent ethyl) as the referenced listed drug, including requirements that generic products co