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Veltassa Approval History

  • FDA approved: Yes (First approved October 21st, 2015)
  • Brand name: Veltassa
  • Generic name: patiromer
  • Dosage form: for Oral Suspension
  • Company: Relypsa, Inc.
  • Treatment for: Hyperkalemia

Veltassa (patiromer) is an oral potassium binder for the treatment of hyperkalemia.

Development History and FDA Approval Process for Veltassa

Nov 27, 2016Approval FDA Approves Supplemental New Drug Application for Veltassa Removing Boxed Warning Regarding Drug-Drug Interactions
Oct 21, 2015Approval FDA Approves Veltassa (patiromer) for Hyperkalemia
Jan  5, 2015Relypsa Announces October 21, 2015 as PDUFA Date for NDA for Patiromer for Oral Suspension
Dec 15, 2014Relypsa Announces FDA Acceptance of New Drug Application for Patiromer for Oral Suspension to Treat Hyperkalemia
Oct 22, 2014Relypsa Submits NDA for Patiromer for Oral Suspension to Treat Hyperkalemia
May 12, 2014Relypsa Announces Topline Results From Patiromer Phase 1 Onset-of-Action Study
Feb  4, 2014Relypsa Completes Enrollment of Phase 1 Onset-of-Action Study for Patiromer

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