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The EMA Committee Has Confirmed Its Opinion for European Marketing Authorization
Jul 26, 2013The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has confirmed its opinion for European marketing authorization of Pfizer's Xeljanz (tofacitinib citrate). Xeljanz is a novel, oral Janus kinase ...
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Tofacitinib Has Obtained Approval in Several Additional Countries Globally
Jul 17, 2013Pfizer's rheumatoid arthritis treatment, tofacitinib, has obtained approval in several additional countries globally, including Switzerland, Argentina, Kuwait, UAE and Russia for patients with inadequate response to current therapies. The ...
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The USFDA Has Accepted Pfizer's Supplemental New Drug Application
Jun 25, 2013The USFDA has accepted Pfizer's supplemental new drug application (sNDA) to expand labeling of rheumatoid arthritis medication Xeljanz (tofacitinib citrate) to include inhibition of structural damage progression. The data from ORAL Start ...
Tags: FDA, Pfizer sNDA, Xeljanz Labeling
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The FDA Arthritis Advisory Committee Has Recommended The Approval of Pfizer's Tofacitinib
Dec 7, 2012The FDA Arthritis Advisory Committee has recommended the approval of Pfizer's Tofacitinib for adult patients with moderately to severely active rheumatoid arthritis (RA). The recommendation will be considered by the FDA in its review of ...
Tags: RA, tofacitinib, rheumatoid arthritis
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Pfizer Has Won US FDA Approval
Dec 5, 2012Pfizer has won US FDA approval for its rheumatoid arthritis (RA) therapy, Xeljanz (tofacitinib citrate) 5mg twice daily, indicated for patients who failed to respond to methotrexate. Xeljanz can be used as a single treatment regime or as ...
Tags: Pfizer, tofacitinib citrate, Xeljanz
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