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December 20, 2013
06:04 EDTAMRNAmarin receives FDA notification that action on ANCHOR sNDA will be delayed
Amarin announced that the FDA notified the company last night that the FDA does not expect to take action on Amarin's supplemental new drug application, or sNDA, for the proposed ANCHOR indication labeling expansion for Vascepa capsules on the December 20 Prescription Drug User Fee Act, or PDUFA, goal date because Amarin's request to reinstate the ANCHOR Special Protocol Assessment , or SPA, agreement remains under consideration with the FDA. No new PDUFA date was established. The FDA also communicated to Amarin that it now views Amarin's appeal of the ANCHOR SPA agreement rescission and the ANCHOR sNDA as separate administrative decisions worthy of separate consideration. FDA plans to complete its review of Amarin's request to reinstate the ANCHOR SPA agreement and plans to convey its decision to Amarin no later than January 15, 2014. The FDA provided no additional information on when it expects to complete its review of the ANCHOR sNDA. Vascepa is currently FDA approved for use as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia. The ANCHOR sNDA seeks approval of Vascepa for use as an adjunct to diet and exercise for adult patients on statin therapy with mixed dyslipidemia and triglyceride levels between 200 and 499 mg/dL. Amarin plans to continue to work with the FDA to pursue reinstatement of the ANCHOR SPA agreement and approval of the ANCHOR sNDA. There can be no assurance that Amarin will be successful in this effort.
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