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Teva Pharmaceuticals, a U.S. affiliate of Teva, announced the print publication of the IMPACT-TD Scale, a standardized and clinician-rated assessment. The scale, developed by a consensus panel, will assist healthcare providers in determining the impact of tardive dyskinesia, or TD, on different aspects of a patient's daily functioning. IMPACT-TD categorizes the consequences of TD symptoms into multiple functional domains: social, psychological/psychiatric, physical and vocational/educational/recreational. The scale was developed to collect insights from not only patients but also family members, caregivers and providers, to help foster more productive dialogue and provide the most comprehensive understanding of the impact of TD.

Teva Pharmaceuticals announced that the U.S. Food and Drug Administration has approved AUSTEDO XR extended-release tablets, a new once-daily formulation indicated in adults for tardive dyskinesia and chorea associated with Huntington's disease. AUSTEDO XR is an additional formulation of the currently marketed twice-daily AUSTEDO. "The approval of AUSTEDO XR is a reflection of our ongoing innovation for people living with TD and HD chorea," said Eric Hughes, MD, PhD, Executive Vice President of R&D and Chief Medical Officer at Teva. "For some patients living with TD and HD, treatment adherence can be a challenge that this new once-daily dosing option can help to address." Once-daily AUSTEDO XR has been shown to be therapeutically equivalent to the twice-daily formulation, providing another effective treatment choice. It will be available in three extended-release tablet strengths - 6 mg, 12 mg, and 24 mg - and can be taken with or without food. The new tablet strengths provide an updated regimen which may result in a decreased pill count for patients compared to the twice-daily formulation.

A letter posted to the site of the FDA indicates that the agency approved the new drug application, or NDA, submitted by Teva Neuroscience, as amended, for the use of Austedo XR 6, 12, and 24 mg tablets for the treatment of chorea associated with Huntington's disease and tardive dyskinesia. Reference Link

In a regulatory filing earlier, Axsome Therapeutics (AXSM) disclosed that on February 10, the company received a Paragraph IV Certification Notice Letter from Teva Pharmaceuticals (TEVA), providing notification to the company that Teva has submitted an Abbreviated New Drug Application, or "ANDA," to the U.S. Food and Drug Administration seeking approval to manufacture, use, or sell a generic version of Auvelity, or dextromethorphan HBr-bupropion HCl. "In the Notice Letter, Teva alleges that four of the patents listed in the FDA Orange Book for Auvelity, U.S. Patent Numbers 10,780,064; 10,925,842; 10,940,124; and 10,966,942, each of which expires in 2040, are invalid, unenforceable, or will not be infringed by Teva's manufacture, use, or sale of the generic product described in its ANDA submission. The Paragraph IV Certification does not challenge any of the remaining Orange Book listed patents for Auvelity which have expirations out to 2034," Axsome stated in the filing.