Posted from: Tuesday, May 31, 2016 - 04:32 PM - Present

Fycompa Oral Solution Approved

April 29, 2016 – The U.S. Food and Drug Administration (FDA) approved Fycompa® (perampanel) CIII oral suspension, manufactured by Elsai. Fycompa is approved for the treatment of partial-onset seizures with or without secondarily generalized seizures, and primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older. This is a new formulation that is bioequivalent and interchangeable with Fycompa tablets, which were originally approved in October 2012. Fycompa oral suspension is expected to be available in June 2016.

 

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 Sunday, September 24, 2017 - 09:26 AM.