Bystolic FDA Approval History
FDA Approved: Yes (First approved December 17, 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 timeline for Bystolic
Date | Article |
---|
Dec 18, 2007 | Approval Bystolic, a Novel Beta Blocker, is Now Approved by the FDA for the
Treatment of Hypertension |
Dec 3, 2007 | FDA Issues Approvable Letter for Bystolic (nebivolol) for the Treatment of
Hypertension |
May 1, 2007 | Response Submitted to FDA Approvable Letter for Hypertension
Compound Nebivolol |
Jun 1, 2005 | Mylan Laboratories Receives Approvable Letter For Its Next Generation Beta-Blocker Nebivolol |
Feb 25, 2005 | FDA Extends PDUFA Action Date for Nebivolol Tablets to May 31, 2005 |
Jul 1, 2004 | Mylan's NDA for Nebivolol Accepted for FDA Review |
May 5, 2004 | Mylan Submits New Drug Application for Nebivolol |
Further information
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