Pharmacia pain drug nixed
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July 13, 2001: 5:17 p.m. ET
FDA deems pain treatment "not approvable" and requests more data
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NEW YORK (CNNfn) - Pharmacia Corp. will have to provide additional data to the Food and Drug Administration to gain approval for a new pain medication.
The company said Friday it will supplement the information already provided for its non-narcotic injectable analgesic parecoxib sodium after receiving a "not approvable" letter from the FDA. Pharmacia plans to have the necessary data ready in 12 to 18 months.
"There has been no advancement in injectable analgesics for the treatment of moderate to severe pain in more than a decade," said Jeffrey Apfelbaum, M.D., professor and chairman of clinical affairs in the department of anesthesia and critical care at the University of Chicago Hospitals, in a statement.
Pharmacia (PHA: Research, Estimates) said the setback would have no impact on 2001 finances and reaffirmed its guidance of 20 percent earnings growth for the year.
Shares of Pharmacia rose 63 cents to $46.85 on the New York Stock Exchange.
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Pharmacia
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