FDA Approves Norliqva (amlodipine) Oral Solution for Hypertension and Coronary Artery Disease


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Hypertension and Coronary Artery Disease

 

February 28, 2022 -- The U.S. Food and Drug Administration has approved Norliqva (amlodipine) oral solution for the treatment of:

  • Hypertension in adults and children 6 years and older, to lower blood pressure.
  • Coronary artery disease [Chronic Stable Angina, Vasospastic Angina (Prinzmetal’s or Variant Angina) and Angiographically Documented Coronary Artery Disease in patients without heart failure or an ejection fraction <40%.]

Amlodipine is a widely used long-acting calcium channel blocker first approved by the FDA thirty years ago. It is a peripheral arterial vasodilator that acts directly on vascular smooth muscle to cause a reduction in peripheral vascular resistance and reduction in blood pressure, and is thought to reduce the total peripheral resistance and inhibit coronary spasm to relieve angina.

Amlodipine is FDA approved under the brand names Norvasc (amlodipine oral tablets) and Katerzia (amlodipine oral suspension), and the oral tablets are also available as generics.

Norliqva is supplied as a peppermint flavored oral solution containing 1 mg/mL amlodipine as the besylate salt. It is administered once daily.

Most common adverse reactions to amlodipine include edema, dizziness, flushing and palpitation which occurred in a dose related manner. Other adverse reactions not clearly dose-related but reported with an incidence >1.0% are fatigue and nausea.

Norliqva is distributed by CMP Pharma, Inc.

Posted: February 2022

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