Celebrex fails to gain label change backing

8 February 2001

A US Food and Drug Administration advisory panel has failed torecommend a change to the labeling of Pharmacia's arthritis drug Celebrex (celecoxib) which would have stated that the COX-2 inhibitor was superior to older non-steroidal anti-inflammatory analgesics in terms of gastrointestinal safety. Pharmacia had hoped to show a safety advantage in order to convince the FDA to relax warnings on the drug's label. Merck & Co's rival drug Vioxx (rofecoxib) was being reviewed for the same superiority claim on February 12, as the Marketletter went to press.

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