Saphris Approved for Pediatric Use
March 13, 2015 - The U.S. Food and Drug Administration (FDA) approved and extended indication for Saphris (asenapine), manufactured by Actavis. Saphris in an atypical antipsychotic medication that has been on the U.S. market for nearly six years and is used for both acute and maintenance treatment of adults with schizophrenia and/or bipolar disorder. Now, Saphris is also approved for treating bipolar disorder I for children as young as 10 years old. For pediatric patients, Saphris will be used alone to manage acute episodes of mania or mixed manic-depressive behaviors resulting from bipolar I disorder.
Saphris is manufactured as sublingual, black-cherry flavored tablets that may be easier for children to take than other oral dose forms. In the second quarter of 2015, a lower strength (2.5mg) will be added to the 5mg and 10mg tablets currently on the market.
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.