Krystexxa Approval History
FDA Approved: Yes (First approved September 14, 2010)
Brand name: Krystexxa
Generic name: pegloticase
Dosage form: Injection
Company: Savient Pharmaceuticals, Inc.
Treatment for: Gout
Krystexxa (pegloticase) is a PEGylated uric acid specific enzyme indicated for the treatment of chronic gout in adult patients refractory to conventional therapy.
Development History and FDA Approval Process for Krystexxa
|Sep 15, 2010|| FDA Approves Krystexxa (pegloticase) for Gout|
|Mar 30, 2010||Savient Announces Krystexxa Resubmitted BLA Accepted for Review by the FDA|
|Mar 19, 2010||Savient Resubmits Biologics License Application for Krystexxa (pegloticase) for the Treatment of Chronic Gout in Patients Refractory to Conventional Therapy|
|Sep 19, 2009||Savient Provides Update on Meeting with U.S. Food and Drug Administration for Krystexxa|
|Aug 4, 2009||Savient Pharmaceuticals Receives Complete Response Letter from U.S. Food and Drug Administration for Krystexxa|
|Jun 17, 2009||FDA Appointed Arthritis Advisory Committee Recommends U.S. Food and Drug Administration Approval for Krystexxa for Refractory Chronic Gout|
|May 7, 2009||Savient Announces New Date for FDA Arthritis Advisory Panel Review of Krystexxa for Treatment Failure Gout|
|Feb 12, 2009||Savient Provides Update on Pegloticase BLA|
|Jan 28, 2009||Savient Announces FDA's Advisory Panel to Review Pegloticase for Treatment-Failure Gout Patients|
|Dec 30, 2008||Pegloticase BLA Filing Accepted for Priority Review by FDA|
|Oct 31, 2008||Savient Submits Biologics License Application (BLA) for Pegloticase|
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