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.
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 contraindicated in patients with sensitivity to amlodipine. About CMP Pharma, Inc. IMPORTANT SAFETY INFORMATION INDICATIONS AND USAGE HYPERTENSION CORONARY ARTERY DISEASE
CONTRAINDICATIONS WARNINGS AND PRECAUTIONS/ADVERSE REACTIONS
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
DOSAGE AND ADMINISTRATION Please click link for full Important Safety Information and full Prescribing Information: NOR-00005 View original content:https://www.prnewswire.com/news-releases/cmp-pharma-inc-announces-that-norliqva-the-first-and-only-fda-approved-liquid-solution-of-amlodipine-is-now-available-301559346.html SOURCE CMP Pharma, Inc. |