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:
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%
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.
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/