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FDA Approves Norliqva

FDA Approves Norliqva (amlodipine) Oral Solution for 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:

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.

FARMVILLE, N.C., June 1, 2022 /PRNewswire/ -- CMP Pharma announced today that Norliqva (Amlodipine) Oral Solution, 1 mg/mL, the first and only FDA-approved oral liquid solution of the besylate salt of amlodipine, a long-acting calcium channel blocker, is now available. Norliqva was approved by the FDA on February 24, 2022 and is now available through normal retail distribution.

Norliqva is the first FDA-approved liquid solution of amlodipine for the treatment of hypertension in patients 6 years of age and older. Norliqva ensures consistent dosing and bioequivalence and counters the complexities and inconsistencies of crushing/compounding amlodipine tablets.

Norliqva does not require refrigeration or shaking, allowing for immediate use and has a shelf life of 36 months. Norliqva's mild peppermint flavor is kid-friendly and meets the unmet needs of pediatric patients as well as older patients who have dysphagia or a difficult time swallowing tablets.

"Norliqva is intended for a subset of the patient population that needs amlodipine but has difficulty swallowing or inability to swallow. The availability of Norliqva gives healthcare providers and appropriate patients a convenient, safe, and FDA-approved liquid solution," said Gerald Sakowski, CEO of CMP Pharma, Inc.

With FDA-approved Norliqva, the challenges around short-term shelf life and lack of dosing consistency of crushed or compounded formulations are addressed. Norliqva is available in 150 mL bottles, which have 36-month dating.

Norliqva (Amlodipine) Oral Solution is now available. For more information, contact CMP Pharma at 252-753-7111 or visit norliqva.com.

About Norliqva
Norliqva is a calcium channel blocker for the treatment of hypertension in adults and children 6 years of age and older, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. Norliqva is also indicated for the treatment of 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%.

Norliqva is contraindicated in patients with sensitivity to amlodipine.

About CMP Pharma, Inc.
CMP Pharma is a specialty pharmaceutical company that addresses critical needs for niche markets by developing and manufacturing a portfolio of high value pharmaceutical products, including oral liquids and semi-solids. CMP Pharma combines decades of experience in pharmaceutical development and manufacturing to provide medicines to fill the unmet medical needs of many patients.

IMPORTANT SAFETY INFORMATION

INDICATIONS AND USAGE
Norliqva is a calcium channel blocker for the treatment of:

HYPERTENSION
Norliqva is indicated for the treatment of hypertension in adults and children 6 years of age and older, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.

CORONARY ARTERY DISEASE

CONTRAINDICATIONS
Norliqva is contraindicated in patients with sensitivity to amlodipine.

WARNINGS AND PRECAUTIONS/ADVERSE REACTIONS
Norliqva may cause the following conditions.

Most common adverse reactions to amlodipine were 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.

Talk to your healthcare provider about other possible side effects with Norliqva. To report SUSPECTED ADVERSE REACTIONS, contact CMP Pharma, Inc. at 1-844-321-1443 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS
Do not exceed doses greater than 20 mg daily of simvastatin.

DOSAGE AND ADMINISTRATION
Norliqva is an oral solution: 1 mg/mL. Adult recommended starting dose: 5 mg orally once daily with a maximum of 10 mg orally once daily. Small, fragile, or elderly patients, or patients with hepatic insufficiency may be started on 2.5 mg orally once daily. Pediatric starting dose: 2.5 mg to 5 mg orally once daily.

Source: CMP Pharma, Inc.

Posted: February 2022

Norliqva (amlodipine besylate) FDA Approval History

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