New Indication for Aptiom
August 28, 2015 – The U.S. Food and Drug Administration (FDA) approved a new indication for Aptiom (eslicarbazepine), manufactured by Sunovion, as a stand-alone treatment for adult patients who experience partial-onset seizures. It was previously only indicated for use in combination with another antiepileptic drug. The recommended starting dose of Aptiom is 400mg once a day which may be increased to a maintenance dose ranging between 800mg and 1600mg once a day. Aptiom tablets are available in four strengths – 200mg, 400mg, 600mg, and 800mg. For patients who are unable to swallow, Aptiom tablets can be crushed.
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.