Pozen, Inc. (MM) (NASDAQ:POZN)
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From May 2019 to May 2024

International healthcare business AstraZeneca PLC (AZN) said Friday it, and Pozen Inc (POZN), have submitted a marketing authorisation application in the European Union via the decentralised procedure for Vimovo tablets.

MAIN FACTS:

-AstraZeneca also said the U.S. Food and Drug Administration has approved Crestor (rosuvastatin calcium) for use in children ages 10-17 with heterozygous familial hypercholesterolemia (HeFH) when diet therapy fails to reduce elevated cholesterol.

-In July, AstraZeneca announced the FDA had granted an additional six-month period of exclusivity to market Crestor (rosuvastatin calcium) for its approved cholesterol and atherosclerosis indications until July 2016.

-Vimovo is under investigation for the treatment of the signs and symptoms of osteoarthritis (OA), rheumatoid arthritis (RA) and ankylosing spondylitis (AS) in patients who are at risk of developing NSAID-associated ulcers.

-In June, Pozen submitted a New Drug Application to the U.S. Food and Drug Administration for Vimovo which was accepted Aug. 31 and is currently under review.

-By London Bureau, Dow Jones Newswires; Contact Ian Walker; +44 (0)20 7842 9296; ian.walker@dowjones.com