Teva gets FDA nod for once-daily Austedo formulation

Feb. 22, 2023

The U.S. FDA has approved a new once-daily formulation of Teva's already marketed drug, Austedo, for adults with tardive dyskinesia (TD) and chorea associated with Huntington’s disease (HD).

Austedo XR,  available in three extended-release tablet strengths, can be taken with or without food. It has been shown to be therapeutically equivalent to the twice-daily formulation currently on the market.

Austedo was first approved in April 2017 for chorea stemming from Huntington's disease, and then later that year for tardive dyskinesiaHD is a fatal neurodegenerative disease characterized by uncoordinated and uncontrollable movements, cognitive deterioration and behavioral and/or psychological problems. TD is a highly debilitating, chronic movement disorder that affects people who take certain mental health treatments and is characterized by uncontrollable, abnormal, and repetitive body movements. 

Austedo is the first and only vesicular monoamine transporter 2 (VMAT2) inhibitor approved by the FDA for both conditions.

According to Teva, the new XR formulation will hit the market later this year.