Ingrezza Approved to Treat Tardive Dyskinesia
April 11 2017 – The U.S. FDA approved Ingrezza™ (valbenazine) capsules for the treatment of adults with tardive dyskinesia (TD). Tardive dyskinesia, which is characterized by abnormal, involuntary movements, affects as many as 500,000 patients in the U.S. Ingrezza is manufactured by Neurocrine Biosciences. The initial dose is 40mg once daily. After a week, it can be increased to the recommended dose of 80mg once daily. Neurocrine plans on a May 1, 2017 launch. It will be available through a limited network of specialty pharmacies.
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.