Elepsia XR Approved to Help Prevent Seizures
March 4, 2015 – The U.S. Food and Drug Administration (FDA) approved Elepsia XR (levetiracetam) extended-release tablets, manufactured by Sun Pharmaceuticals. Elepsia XR is indicated for use as a once-daily add-on therapy to other medications in the treatment of partial onset epileptic seizures for individuals who are at least 12 years old. Elepsia XR will be available as 1000 mg and 1500 mg tablets. These expected strengths of Elepsia XR are higher strengths than those available in levetiracetam products such as the brand drug Keppra and generics. Sun Pharmaceuticals has not yet announced launch plans, set pricing or released full prescribing information.
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.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.