Pharmacia Corporation and Pfizer Inc Receive Approvable Letter for Revised Labeling for CELEBREX(R)

Apr 12, 2001, 01:00 ET from Pharmacia Corporation and Pfizer Inc

    PEAPACK, N.J., April 12 /PRNewswire/ -- Pharmacia Corporation
 (NYSE:   PHA) and Pfizer Inc announced today that they have received an
 approvable letter from the U.S. Food and Drug Administration (FDA) for revised
 labeling for CELEBREX(R) (celecoxib capsules), the only COX-2 specific
 inhibitor approved for both osteoarthritis (OA) and adult rheumatoid arthritis
 (RA).  The approvable letter is in response to the supplemental new drug
 application seeking changes to the prescribing information to include results
 of the Celecoxib Long-term Arthritis Safety Study (CLASS).
     An approvable letter is a written statement that indicates the FDA's
 willingness to approve an application, should specific additional information
 or material be submitted or specific conditions be met.  An approvable letter
 does not constitute an approval of the application.  The supplemental new drug
 application was submitted on June 13, 2000.
     Pharmacia and Pfizer are confident that all previous studies, including
 CLASS, comparing CELEBREX to traditional NSAIDs in approximately
 20,000 patients -- post-marketing surveillance in more than 12 million
 patients and nearly 2 million patient-years of exposure -- have demonstrated
 that CELEBREX is effective, well tolerated and offers an excellent GI safety
 profile.
 
     Additional Information
     CELEBREX is the only COX-2 specific inhibitor approved for both
 osteoarthritis (OA) and adult rheumatoid arthritis (RA).
     CELEBREX should not be taken by patients who have aspirin-sensitive asthma
 or allergic reactions to aspirin or other arthritis medicines or certain sulfa
 drugs called sulfonamides, or who are in their third trimester of pregnancy.
 As with all NSAIDs, serious GI tract ulcerations can occur without warning
 symptoms. Physicians and patients should remain alert to the signs and
 symptoms of GI bleeding. CELEBREX(R) does not affect platelet function and
 therefore should not be used for cardiovascular prophylaxis. There have been
 infrequent post-marketing reports of increases in prothrombin time, sometimes
 associated with bleeding events, predominantly in the elderly. Anticoagulant
 activity should be monitored when therapy with CELEBREX is initiated or
 changed in patients taking warfarin, particularly in the first few days.  In
 studies, the most common side effects of CELEBREX were dyspepsia, diarrhea and
 abdominal pain, which were generally mild to moderate.
     The drug is marketed by Pharmacia Corporation and Pfizer Inc.  Pharmacia
 Corporation (NYSE:   PHA) is a leading global pharmaceutical company created
 through the merger of Pharmacia & Upjohn with Monsanto Company and its G.D.
 Searle unit. Pharmacia has a broad product portfolio, a robust pipeline of new
 medicines, and an annual investment of more than $2 billion in pharmaceutical
 research and development.
     Pfizer Inc discovers, develops, manufactures and markets leading
 prescription medicines, for humans and animals, and many of the world's
 best-known consumer products.  Pfizer had global revenues of $29.6 billion in
 2000.  Pfizer plans to make a research and development investment of about
 $5 billion in 2001.
 
 

SOURCE Pharmacia Corporation and Pfizer Inc
    PEAPACK, N.J., April 12 /PRNewswire/ -- Pharmacia Corporation
 (NYSE:   PHA) and Pfizer Inc announced today that they have received an
 approvable letter from the U.S. Food and Drug Administration (FDA) for revised
 labeling for CELEBREX(R) (celecoxib capsules), the only COX-2 specific
 inhibitor approved for both osteoarthritis (OA) and adult rheumatoid arthritis
 (RA).  The approvable letter is in response to the supplemental new drug
 application seeking changes to the prescribing information to include results
 of the Celecoxib Long-term Arthritis Safety Study (CLASS).
     An approvable letter is a written statement that indicates the FDA's
 willingness to approve an application, should specific additional information
 or material be submitted or specific conditions be met.  An approvable letter
 does not constitute an approval of the application.  The supplemental new drug
 application was submitted on June 13, 2000.
     Pharmacia and Pfizer are confident that all previous studies, including
 CLASS, comparing CELEBREX to traditional NSAIDs in approximately
 20,000 patients -- post-marketing surveillance in more than 12 million
 patients and nearly 2 million patient-years of exposure -- have demonstrated
 that CELEBREX is effective, well tolerated and offers an excellent GI safety
 profile.
 
     Additional Information
     CELEBREX is the only COX-2 specific inhibitor approved for both
 osteoarthritis (OA) and adult rheumatoid arthritis (RA).
     CELEBREX should not be taken by patients who have aspirin-sensitive asthma
 or allergic reactions to aspirin or other arthritis medicines or certain sulfa
 drugs called sulfonamides, or who are in their third trimester of pregnancy.
 As with all NSAIDs, serious GI tract ulcerations can occur without warning
 symptoms. Physicians and patients should remain alert to the signs and
 symptoms of GI bleeding. CELEBREX(R) does not affect platelet function and
 therefore should not be used for cardiovascular prophylaxis. There have been
 infrequent post-marketing reports of increases in prothrombin time, sometimes
 associated with bleeding events, predominantly in the elderly. Anticoagulant
 activity should be monitored when therapy with CELEBREX is initiated or
 changed in patients taking warfarin, particularly in the first few days.  In
 studies, the most common side effects of CELEBREX were dyspepsia, diarrhea and
 abdominal pain, which were generally mild to moderate.
     The drug is marketed by Pharmacia Corporation and Pfizer Inc.  Pharmacia
 Corporation (NYSE:   PHA) is a leading global pharmaceutical company created
 through the merger of Pharmacia & Upjohn with Monsanto Company and its G.D.
 Searle unit. Pharmacia has a broad product portfolio, a robust pipeline of new
 medicines, and an annual investment of more than $2 billion in pharmaceutical
 research and development.
     Pfizer Inc discovers, develops, manufactures and markets leading
 prescription medicines, for humans and animals, and many of the world's
 best-known consumer products.  Pfizer had global revenues of $29.6 billion in
 2000.  Pfizer plans to make a research and development investment of about
 $5 billion in 2001.
 
 SOURCE  Pharmacia Corporation and Pfizer Inc