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Biotech / Medical : PFE (Pfizer) How high will it go?
PFE 25.19+0.6%Dec 19 9:30 AM EST

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To: JEB who wrote (6594)1/1/1999 11:05:00 AM
From: BigKNY3  Read Replies (1) of 9523
 
Monsanto - FDA -2: Celebrex Not Considered New Drug Class
By Otesa Middleton

12/31/98
Dow Jones News Service

WASHINGTON (Dow Jones)--Monsanto Co.'s (MTC) Celebrex won approval from the U.S. Food and Drug Administration Thursday, making it the first Cox-2 inhibitor cleared by the agency.

The FDA approved the drug for rheumatoid arthritis and osteoarthritis.

The drug works by inhibiting the enzyme cyclooxygenase-2, called Cox-2, which causes inflammation.

The agency's release said Celebrex is a member of the NSAID, or non-steroidal anti-inflammatory drug class, which includes ibuprofen, aspirin and other popular pain killers.

One of the most common side effects of NSAIDs is gastrointestinal ulcers, which are believed to be caused because other NSAIDs block both Cox-1 and Cox-2.

Cox-1 is thought to protect the stomach lining. "It is therefore hoped that Celebrex will have safety advantages compared to other NSAID products," the FDA's release said.

When Monsanto applied for Celebrex's approval, the company asked the drug be considered the first in a new class of drugs that only work to inhibit Cox-2.

A federal panel had advised the agency that the drug should still be considered an NSAID
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