Posted from: Tuesday, September 08, 2015 - 11:43 AM - Present

Spritam Approval for Treating Seizures

August 3, 2015 – The U.S. Food and Drug Administration (FDA) granted approval to Aprecia Pharmaceutical for Spritam (levetiracetam). Spritam is indicated for the treatment of epileptic seizures, as an add-on therapy for treating myoclonic seizures, partial onset seizures, and primary generalized tonic-clonic seizures in adults and children. Manufactured by a 3-D printing process that uses Aprecia’s proprietary ZipDose technology, Spritam’s unique process allows layers of powdered medication to be formed into spongy, mint flavored tablets that disintegrate very quickly when taken.  The recommended dose for Spritam is one tablet twice daily with a small amount of liquid. Dosage strengths will be available in 250mg, 500mg, 750mg, and 1,000mg, and will be packaged individually on blister sheets with 60 tablets per box.

 

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. All trademarks are the property of their respective owners.

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

 

Last Updated Tuesday, October 17, 2017 - 12:19 AM.