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Krystexxa Approval History

  • FDA approved: Yes (First approved September 14th, 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

DateArticle
Sep 15, 2010Approval FDA Approves Krystexxa (pegloticase) for Gout
Mar 30, 2010Savient Announces Krystexxa Resubmitted BLA Accepted for Review by the FDA
Mar 19, 2010Savient Resubmits Biologics License Application for Krystexxa (pegloticase) for the Treatment of Chronic Gout in Patients Refractory to Conventional Therapy
Sep 19, 2009Savient Provides Update on Meeting with U.S. Food and Drug Administration for Krystexxa
Aug  4, 2009Savient Pharmaceuticals Receives Complete Response Letter from U.S. Food and Drug Administration for Krystexxa
Jun 17, 2009FDA Appointed Arthritis Advisory Committee Recommends U.S. Food and Drug Administration Approval for Krystexxa for Refractory Chronic Gout
May  7, 2009Savient Announces New Date for FDA Arthritis Advisory Panel Review of Krystexxa for Treatment Failure Gout
Feb 12, 2009Savient Provides Update on Pegloticase BLA
Jan 28, 2009Savient Announces FDA's Advisory Panel to Review Pegloticase for Treatment-Failure Gout Patients
Dec 30, 2008Pegloticase BLA Filing Accepted for Priority Review by FDA
Oct 31, 2008Savient Submits Biologics License Application (BLA) for Pegloticase

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