AMARIN PARTNER EDDINGPHARM RECEIVES REGULATORY APPROVAL FOR VASCEPA® (ICOSAPENT ETHYL) IN MAINLAND CHINA
-- VASCEPA Approved by the National Medical Products Administration (NMPA) as an Adjunct to Diet to Reduce Triglyceride Levels in Adult Patients with Severe Hypertriglyceridemia (= 500 mg/dL) --
-- EddingPharm Now Working Towards Preparing for Commercial Launch of VASCEPA Across Mainland China Expected by Year-End --
DUBLIN, Ireland and BRIDGEWATER, N.J., June 01, 2023 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today announced that its commercial partner in China, EddingPharm (EDDING), has received regulatory approval for VASCEPA® (icosapent ethyl) from China’s National Medical Products Administration (NMPA). NMPA granted approval for VASCEPA as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia (=500 mg/dL).
Following regulatory approval, EDDING is now focusing on National Reimbursement Drug Listing (NRDL) and preparing for commercial launch in China, expected by year-end, as well as on advancing regulatory submission and review for an additional indication in cardiovascular risk reduction (CVRR).
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gaat er nieuwe fanta komen in dit aandeel nu ook Sarissa erin zit (Denner)