CMP Pharma, Inc Announces that Norliqva®, the First and Only FDA-approved Liquid Solution of Amlodipine, is Now Available

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 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

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

  • Chronic Stable Angina
  • Vasospastic Angina (Prinzmetal’s or Variant Angina)
  • Angiographically Documented Coronary Artery Disease In patients without heart failure or an ejection fraction <40%

CONTRAINDICATIONS

NORLIQVA is contraindicated in patients with sensitivity to amlodipine.

WARNINGS AND PRECAUTIONS/ADVERSE REACTIONS

NORLIQVA may cause the following conditions.

  • Symptomatic hypotension is possible, particularly in patients with severe aortic stenosis. However, acute hypotension is unlikely.
  • Worsening angina and acute myocardial infarction can develop after starting or increasing the dose of NORLIQVA, particularly in patients with severe obstructive coronary artery disease.
  • Titrate slowly in patients with severe hepatic impairment.

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.

  • CYP3A Inhibitors: Co-administration with CYP3A inhibitors (moderate and strong) results in increased systemic exposure to amlodipine and may require dose reduction.
  • CYP3A Inducers: No information is available on the quantitative effects of CYP3A inducers on amlodipine. Blood pressure should be closely monitored when amlodipine is co-administered with CYP3A inducers.
  • Simvastatin: Co-administration of simvastatin with amlodipine increases the systemic exposure of simvastatin. Limit the dose of simvastatin in patients on amlodipine to 20 mg daily
  • Immunosuppressants: Amlodipine may increase the systemic exposure of cyclosporine or tacrolimus when co- administered.

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.

Please click link for full Important Safety Information and full Prescribing Information: https://www.norliqva.com/prescribing-information/

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