Posted from: Monday, October 09, 2017 - 06:16 PM - Present

Austedo Approved for Tardive Dyskinesia

August 30, 2017 – The U.S. FDA has approved Austedo® (deutetrabenazine), manufactured by Teva Pharmaceuticals, to treat tardive dyskinesia. The drug is believed to temporarily decrease the amounts of monoamines—including dopamine and serotonin—within the brain; this may help to modulate signals between nerves in the body.

Tardive dyskinesia is a side effect that results from the long-term use of certain drugs, including antipsychotic medications. It is characterized by uncontrollable movements, primarily of the face, though it can also affect other parts of the body. Austedo was originally approved earlier this year to treat adult patients with chorea, a condition similar to tardive dyskinesia and caused by Huntington’s disease.

Recommended dosing of Austedo for treatment of tardive dyskinesia is 12mg per day to start, with increases made at weekly intervals if necessary, up to a maximum of 48mg per day. Austedo carries a black box warning cautioning that patients may experience an increase in symptoms of depression and thoughts of suicide.

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 Wednesday, September 18, 2019 - 12:36 AM.