Posted by Michael Wonder on 18 Jan 2024
US FDA declines to approve Shin Nippon Biomedical's migraine drug
17 January 2024 - The US health regulator has declined to approve Japan-based Shin Nippon Biomedical Laboratories' treatment for acute migraine late on Wednesday, citing manufacturing concerns.
Japan listed stock of Shin Nippon, which acquired the drug through its purchase of Satsuma Pharmaceuticals in April last year.
Shin Nippon Biomedical Laboratories said the complete response letter from the FDA did not indicate any concerns related to the data nor was there any request for additional information.
