Posted from: Friday, November 10, 2017 - 05:41 PM - Present

New Strength Approved for Ingrezza

October 5, 2017 – The U.S. FDA has approved a new 80mg strength of Ingrezza® (valbenazine) capsules, manufactured by Neurocrine Biosciences, and indicated to treat adults with tardive dyskinesia (TD). Tardive dyskinesia results from the long-term use of certain drugs, such as antipsychotics, and causes uncontrollable movement, most often in the face, but also in other areas of the body.

A vesicular monoamine transporter 2 (VMAT2) inhibitor, Ingrezza has a recommended initial dose of 40mg per day in the first week. An increase to 80mg per day is recommended for the majority of patients following the first week.

Neurocrine Biosciences has already launched the new 80mg capsules.

 

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.

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.

Last Updated Sunday, May 27, 2018 - 03:10 AM.