Expanded Indication for Latuda
January 28, 2017 - The U.S. FDA approved Latuda® (lurasidone) which is indicated to treat schizophrenia for patients between 13 years and 18 years old. Latuda is manufactured by Sunovion Pharmaceuticals. Recommended dosing is one tablet daily taken with food. Latuda can be used alone or in combination with other drugs, such as lithium. Clinical studies of its effectiveness for teens lasted six weeks. Therefore, prescribers are advised to evaluate the need for treatment if therapy lasts longer. Latuda, an atypical antipsychotic, also is approved to treat adults who have schizophrenia or major depression related to bipolar disorder.
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 U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. 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 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.