Final approval was not given because of a patent issue; Biogen had a patent on its Tecfidera delayed-release capsules until an appeals court deemed it invalid in late 2021.
The FDA and Aurobindo Pharma did not reply to Becker’s requests for comment by publication time. This article will be updated if more information becomes available.
At the Becker's 11th Annual IT + Revenue Cycle Conference: The Future of AI & Digital Health, taking place September 14–17 in Chicago, healthcare executives and digital leaders from across the country will come together to explore how AI, interoperability, cybersecurity, and revenue cycle innovation are transforming care delivery, strengthening financial performance, and driving the next era of digital health. Apply for complimentary registration now.
