|
The U.S. Food and Drug Administration (FDA) won’t approve Merck & Co.’s new arthritis drug and pain reliever Arcoxia™ (etoricoxib) until the agency sees more data about the drug’s safety and effectiveness.
Arcoxia is viewed as a successor to Merck’s pain reliever Vioxx that was pulled off pharmacy shelves last month because of heart attack and stroke risks.
The FDA indicated that it may still approve the drug once its conditions are met in a letter that Merck confirmed it had received on October 29.
Arcoxia is already available for use in 48 counties.
Merck said it would work with the FDA to address what steps need to be taken before the application may be approved.
"We continue to believe that ARCOXIA has the potential to become a valuable treatment option for many Americans with arthritis and pain," said Raymond V. Gilmartin, Merck’s chairman, president and chief executive officer.
Source:
Medical Week Staff, week
of October 30, 2004
|
HOME PAGE
