Teva Pharmaceutical Industries said that its US affiliate Teva Pharmaceuticals has secured approval for AUSTEDO XR (deutetrabenazine) extended-release tablets from the US Food and Drug Administration (FDA) for tardive dyskinesia (TD) and chorea associated with Huntington’s disease (HD). AUSTEDO XR is a new daily once formulation. Expected to be launched in the US later this […]
Zydus Lifesciences (previously called Cadila Healthcare) said that its subsidiary Zydus Worldwide DMCC has been given tentative approval from the US Food and Drug Administration (FDA) for Valbenazine Capsules USP 40 mg, 60 mg, and 80 mg. The product is a generic of Neurocrine Biosciences’ Ingrezza, which was approved by the FDA in 2017. According […]
The US Food and Drug Administration (FDA) has approved for Ingrezza (valbenazine) capsules developed by Neurocrine Biosciences for the treatment of tardive dyskinesia patients.
Neurocrine Biosciences has achieved a major milestone with the U.S. Food and Drug Administration (FDA) approving its medication, Ingrezza (valbenazine) capsules, for the treatment of adults with tardive dyskinesia. This approval marks Ingrezza as the first drug of its kind, a selective vesicular monoamine transporter 2 (VMAT2) inhibitor, specifically approved to address this neurological condition. […]