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.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
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