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Exforge Approval History

  • FDA approved: Yes (First approved June 20th, 2007)
  • Brand name: Exforge
  • Generic name: amlodipine and valsartan
  • Dosage form: Tablets
  • Company: Novartis
  • Treatment for: High Blood Pressure

Exforge is a single-tablet combination of an angiotensin receptor blocker (valsartan) and a calcium channel blocker (amlodipine) taken once-daily for the treatment of hypertension.

Development History and FDA Approval Process for Exforge

Aug  4, 2008Approval Single-Pill Combinations Diovan HCT and Exforge Approved in US as First-Line Treatments for High Blood Pressure
Jun 21, 2007Approval Exforge Receives Final US Approval as New and Powerful Treatment Option for Patients With High Blood Pressure
Apr 27, 2006US Submission of Exforge Accepted for Review by the FDA

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