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Merck Receives 'Approvable' Letter from FDA on New Drug Application for ARCOXIA.
WHITEHOUSE STATION, N.J. -- Merck & Co., Inc. today confirmed that it has received an "approvable" letter from the U.S. Food and Drug Administration (FDA) for the company's New Drug Application (NDA) for ARCOXIA(TM) (etoricoxib).
The FDA has informed Merck in the letter that before approval of the NDA can be issued, additional safety and efficacy data for ARCOXIA are required.
"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, chairman, president and chief executive officer, Merck & Co., Inc. "We plan to work with the FDA to address what steps…
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Source: HighBeam Research, Merck Receives 'Approvable' Letter from FDA on New Drug Application...
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