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.
- 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 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.