July 29, 2016 – The FDA approved Qbrelis™ (lisinopril oral solution), manufactured by Silvergate Pharmaceuticals, for the treatment of high blood pressure in adults and children at least six years of age. It is the first oral liquid formulation of the angiotensin-converting enzyme (ACE) inhibitor, lisinopril. Qbrelis is also approved for use as an adjunct (add-on) therapy for heart failure and treatment of acute myocardial infarctions (heart attacks). It will be available in a 150 mL bottle containing 1 mg/mL of lisinopril solution.
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 regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular 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
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.