Posted from: Monday, March 02, 2015 - 04:56 PM - Present

Label Expanded for Banzel

The U.S. Food and Drug Administration (FDA) approved Banzel (rufinamide) for use as an adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in pediatric patients from one to four years of age. Banzel, manufactured by Eisai, was originally approved in 2008 for the same indications, but was limited for use in adults and children as young as four years of age. Banzel is available as 200mg and 400mg film-coated tablets, and a 40mg/mL oral suspension.

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.

 

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

 

Last Updated Saturday, August 19, 2017 - 02:37 PM.