India-based drugmaker Aurobindo Pharma received a tentative approval from the FDA for its dimethyl fumarate capsules to treat multiple sclerosis, CNBC reported Dec. 27.
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.