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NEWS - Centocor submits application to FDA requesting approval of golimumab for the treatment of RA

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Centocor, Inc. Submits Application To FDA Requesting Approval Of

Golimumab For The Treatment Of Rheumatoid Arthritis

MedicalNewsToday.com

Article Date: 28 Jun 2008 - 0:00 PDT

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Centocor, Inc. announced that a Biologics License Application (BLA)

has been submitted to the U.S. Food and Drug Administration (FDA)

requesting the approval of golimumab (CNTO 148) as a monthly

subcutaneous treatment for adults with active forms of rheumatoid

arthritis, psoriatic arthritis and ankylosing spondylitis. Golimumab,

Centocor's next-generation human anti-TNF-alpha monoclonal antibody,

is being studied as an every four week subcutaneous injection and is

also being studied as an intravenous (IV) infusion therapy. In

February 2008, Centocor submitted a Marketing Authorization

Application (MAA) to the European Medicines Agency (EMEA) requesting

the approval of golimumab as a monthly subcutaneous treatment for the

same indications.

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Read the entire article here:

http://www.medicalnewstoday.com/articles/113167.php

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Not an MD

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