Merck's Arcoxia Receives Approval in the United Kingdom
4/15/2002
WHITEHOUSE STATION, N.J. -(Dow Jones)- Merck & Co .'s (MRK) Arcoxia
received approval in the U.K. as a once-daily medicine for the treatment of
osteoarthritis and rheumatoid arthritis.
Aroxia also relieves chronic musculo-skeletal pain, including chronic low
back pain. It also treats acute pain associated with dental surgery and primary
dysmenorrhea, or painful menstruation.
In a press release Monday, Merck said the U.K. is the first country in the
European Union to grant medical approval to Arcoxia. Arcoxia currently is
approved for similar indications in Mexico , Brazil and Peru .
(This story was originally published by Dow Jones Newswires)
In the U.S. , Merck has withdrawn its original application for Arcoxia and
plans to submit an expanded New Drug Application to the Food and Drug
Administration .
The new application will include new efficacy data to support an indication
for ankylosing spondylitis - a disease that affects joints in the spine.
The company believes this indication will better position the product to
compete successfully in the coxib class in the U.S. , where there already are
three entrants: its own Vioxx and two drugs co -produced by Pharmacia Corp. (PHA)
and Pfizer Inc. (PFE), Celebrex and Bextra.