Posted from: Tuesday, February 06, 2018 - 11:54 AM - Present

First Oral Liquid form of Valsartan Approved

December 19, 2017 – The U.S. FDA has approved Prexxartan (valsartan) oral solution, manufactured by Medicure. This is the first oral liquid form of valsartan approved for use in the United States.

Prexxartan is an angiotensin II receptor blocker (ARB) indicated to treat hypertension in adults and children at least six years of age by helping to lower blood pressure. In addition, it carries two indications for patients who are unable to swallow valsartan tablets: 1) to reduce the risk of hospitalization for patients with NYHA class II-IV heart failure, and 2) to reduce the risk of cardiovascular mortality in patients with stable left ventricular failure or left ventricular dysfunction following myocardial infarction.

Although Prexxartan contains the same active ingredient as valsartan tablets, the two formulations are not considered therapeutically equivalent. Recommended dosing with Prexxartan is based on indication, with dosage for hypertension determined by the patient’s age and, for pediatric patients, body weight. A black box warning cautions that Prexxartan should be discontinued if the patient becomes pregnant, due to the risk of fetal toxicity.

Product launch is expected during the first half of 2018. Prexxartan will be available in 120mL and 473mL bottles containing a 4mg/mL of solution. The manufacturer has not yet announced pricing information.

 

Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.

Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval.  Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval.  Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.

*This is provided for information only.  The reference to any medication above does not mean the medication is covered by your plan.

Last Updated Wednesday, July 18, 2018 - 12:10 AM.