Posted from: Monday, August 01, 2016 - 01:03 PM - Present

Expanded Indications of Berinert Approved

July 18, 2016 – The U.S. FDA approved an expansion to the indications for Berinert® [C1 esterase inhibitor (human)], manufactured by CSL Behring. Originally Berinert was approved in 2009 to treat hereditary angioedema (HAE) attacks in patients 12 years of age and older, it now also is approved for the treatment of children younger than 12.

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.

Actual drug patent expiration dates and a 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.

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Last Updated Monday, October 14, 2019 - 03:06 PM.