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Bystolic Approval History

  • FDA approved: Yes (First approved December 17th, 2007)
  • Brand name: Bystolic
  • Generic name: nebivolol
  • Company: Allergan plc
  • Treatment for: High Blood Pressure

Bystolic (nebivolol) is a once daily beta blocker approved for the treatment of hypertension.

Development History and FDA Approval Process for Bystolic

Dec 18, 2007Approval Bystolic, a Novel Beta Blocker, is Now Approved by the FDA for the Treatment of Hypertension
Dec  3, 2007FDA Issues Approvable Letter for Bystolic (nebivolol) for the Treatment of Hypertension
May  1, 2007Response Submitted to FDA Approvable Letter for Hypertension Compound Nebivolol
Jun  1, 2005Mylan Laboratories Receives Approvable Letter For Its Next Generation Beta-Blocker Nebivolol
Feb 25, 2005FDA Extends PDUFA Action Date for Nebivolol Tablets to May 31, 2005
Jul  1, 2004Mylan's NDA for Nebivolol Accepted for FDA Review
May  5, 2004Mylan Submits New Drug Application for Nebivolol

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