AstraZeneca Submits EU Marketing Application For Vimovo
16 Ottobre 2009 - 2:45PM
Dow Jones News
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